UK MHRA has issued a Medical Device Alert relating to Bivona® Neonatal, Pediatric and Flextend Tracheostomy Tubes manufactured by Smiths Medical.
Alerts/Adverse Events
FDA Warning Letter To J&J Subsidiary Diabetes Pump Company
It’s all good news for J&J as another of its divisions faces a telling off from FDA.
PIP: A Vision Of The Future? Really?
In this editorial we ask whether it’s joined up thinking to claim that the PIP situation, just because it’s a private sector issue, means all private healthcare will be riddled with problems and providers not willing to cooperate on their solution?
Uro/Gyne Surgical Mesh Implants: FDA Updates Position
FDA has announced a heightened degree of scrutiny regarding transvaginally inserted meshes and is considering reclassifying from Class II to Class III.
Medical Device Alert: Octopus 3 Extension Set With Antireflux Valves And Clamps Manufactured By Vygon
UK MHRA has issued a Medical Device Alert(MDA) relating to Vygon’s Octopus 3 extension set with antireflux valves and clamps, which have been identified as at possible risk of failure to deliver therapy under gravity infusion.
St Jude Launches Website Dedicated To Riata Silicone Lead Management
St. Jude Medical, Inc. has launched a Riata Lead Communication website to provide physicians with a compilation of important communications and updated information regarding the recent Riata® and Riata® ST Silicone Defibrillation Leads Class I recall.
PIP: One Bad Apple?
While we can all point fingers at the PIP breast implant situation as being a one-off, all parties must look in the mirror to ensure this is used as a lesson in how things can go wrong.
PIP Breast Implants: How Did This Happen?
medlatest speculates about whether regulatory controls are tight enough when a company can substitute “mattress grade” silicone for that which was approved in the regulatory process.
St Jude Riata Voluntary Recall Judged By FDA as Class 1
12 months after European regulators issued alerts, St. Jude Medical, Inc. has now announced that following its voluntary medical device advisory letter to physicians from Nov. 28, 2011 the U.S. Food and Drug Administration (FDA) has now classified this action as a Class I Recall.
Medical Device Alert: Molnlycke Health Care ProcedurePaks®
UK MHRA has issued a Medical Device Alert relating to Molnlycke Health Care ProcedurePaks® with devices containing latex, which have been labelled as latex-free.
Medical Device Alert: Auxiliary Common Gas Outlet on Aestiva, Aisys, Aespire and Avance Anaesthetic Machinesed by Lifecare Hospital Supplies Ltd
UK MHRA has issued a Medical Devices Alert(MDA) relating to the Auxiliary Common Gas Outlet (ACGO) on all Aestiva, Aisys, Aespire and Avance anaesthetic machines manufactured by GE Healthcare.
Medical Device Alert on Venturi Air Entrainment Jet Adapters manufactured by Lifecare Hospital Supplies Ltd
UK MHRA has issued a Medical Devices Alert on Venturi Air Entrainment Jet Adapters supplied in kits with Oxygen facemasks and Tubing, manufactured by Lifecare Hospital Supplies Ltd.
Medical Device Alert on Crystal® Metal Disposable Laryngoscope Blades
Medical Device Alert: Crystal® Metal disposable laryngoscope blades (size Mac 4) manufactured by Penlon Ltd (MDA/2011/101)
FDA Reports Growth in Medical Device Adverse Events
Medtech Business reports FDA’s observations that growth in reported serious adverse events has outpaced revenue growth by 8% each year in the past decade.
Medical Device Alert on Aquarius Haemofiltration Device
UK MHRA has issued a Medical Device Alert (MDA) on the Aquarius Haemofiltration Device manufactured by Nikkiso Europe GmBH and distributed by Baxter Healthcare.
UK MHRA Review of Medical Device Incidents Report Published
UK MHRA report shows 13% uplift in adverse incident reports year on year.