BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD PARKER/ASPEN SURGICAL #11 PROTECTED BLADE

    MDR report key: 13118232 · Received December 29, 2021

    Report

    Report Number
    MW5106369
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Date of Event
    March 16, 2021
    Report Date
    December 27, 2021
    Manufacturer
    ASPEN SURGICAL PUERTO RICO CORP.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE SAFETY BLADE THAT WAS OPENED FOR THE PROCEDURE DID NOT FUNCTION PROPERLY - THE PROTECTION OVER THE BLADE WOULD NOT SLIDE OPEN. A NEW BLADE WAS OPENED AND THE SURGERY WAS COMPLETED WITHOUT INCIDENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014008 BARD PARKER/ASPEN SURGICAL #11 PROTECTED BLADE BLADE, SCALPEL GES ASPEN SURGICAL PUERTO RICO CORP. REF 373911 0230370

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female