BEUDAMED
    FDA Adverse Event Other Summary report: N

    SKIN CLOSURES- FLEXIBLE

    MDR report key: 2987917 · Received February 21, 2013

    Report

    Report Number
    1836161-2013-00017
    Event Type
    Other
    Date Received
    February 21, 2013
    Date of Event
    April 22, 2010
    Report Date
    February 21, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    FPX
    PMA / PMN Number
    K874813
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: PRODUCTS RECEIVED AND MEET SPECIFICATION. RESULTS: MET SPECIFICATIONS. CONCLUSIONS: DEVICE WAS USED WITH AN ADHESIVE ACCELERATOR. THE DEVICE IS NOT INTENDED TO BE USED WITH AN ADHESIVE ACCELERATOR.

    Description of Event or Problem · 1

    STRIPS ARE PRODUCING A SKIN REACTION RECENTLY; REDNESS AND BLISTERING. DOCTOR HAS RULED OUT OTHER CAUSES AND WHILE NOT 100% POSITIVE, IT IS STRONGLY SUSPECTED IT IS FROM THIS ITEM. MULTIPLE LOTS WERE MIXED IN ONE BIN AND ALL HAVE BEEN PULLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75116 SKIN CLOSURES- FLEXIBLE SKIN CLOSURE- FLEXIBLE FPX ASPEN SURGICAL PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other