BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL FOAM

    MDR report key: 4151889 · Received October 6, 2014

    Report

    Report Number
    1049092-2014-00523
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 10, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. IT WAS FURTHER REPORTED THAT THE COMMUNITY NURSE WAS UNABLE TO NAME THE SIZE USED, PRODUCT NUMBER, DATE, PREVIOUS DRESSING USED AND WHAT TREATMENT WAS USED POST DRESSING REACTION; HOWEVER, THE NURSE DID STATE THAT ALL FOUR PATIENTS HAD VENOUS LEG ULCERATION. THE PRODUCT WAS IN USE 1 TO 3 DAYS BEFORE THE EVENT OCCURRED. THE DRESSING WAS DISCONTINUED. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2014 WHICH STATED "THE DRESSING DID NOT CAUSE THE ULCERS; ALL ULCERS WERE PRESENT PRIOR TO AQUACEL FOAM APPLICATION." THIS CASE IS TO IDENTIFY PT 1 WHICH INVOLVED VENOUS LEG ULCERATION AND REDNESS. NOTE: ISSUE OCCURRED ON (4) SEPARATE CASES. A SEPARATE 3500A FORM HAS BEEN COMPLETED FOR THE OTHER (3) CASES. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR PATIENTS EXPERIENCED A REACTION TO AQUACEL FOAM ADHESIVE WITH SURROUNDING REDNESS. AS A RESULT, ONE PT EXPERIENCED BLISTERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622449 AQUACEL FOAM 79NAC NAC CONVATEC INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention