BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL AG - SURGICAL COVER DRESSINGS

    MDR report key: 4101109 · Received September 17, 2014

    Report

    Report Number
    1049092-2014-00488
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    CONVATEC, INC
    Product Code
    FRO
    PMA / PMN Number
    K091034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. AN ATTEMPT HAS BEEN MADE TO OBTAIN FURTHER INFO; HOWEVER, NO ADDITIONAL INFO HAS BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO FDA ON (B)(4) 2014. THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    IT WAS REPORTED SKIN BLISTERED UNDER ADHESIVE. TIME FRAME DRESSING WAS IN PLACE AND OUTCOME UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576698 AQUACEL AG - SURGICAL COVER DRESSINGS FRO CONVATEC, INC 420670 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1