BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUACEL FOAM

    MDR report key: 3934396 · Received June 27, 2014

    Report

    Report Number
    1049092-2014-00240
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    CONVATEC INC
    Product Code
    NAC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO SAMPLE WAS AVAILABLE FOR EVALUATION; HOWEVER, AN INVESTIGATION WAS PERFORMED BY THE THIRD PARTY MANUFACTURER, (B)(4), INITIATED ON (B)(4) 2014 AND CLOSED ON (B)(4) 2014 BASED ON THE REVIEW OF DEVICE HISTORY RECORDS, STERILIZATION RECORDS AND RETAIN SAMPLES FOR (B)(4) PRIOR BATCHES. RESULTS SHOWED NO NON-CONFORMANCE DURING THE MANUFACTURING, PACKAGING, OR STERILIZATION PROCESSES. (B)(4) REPORTS THAT THIS COMPLAINT IS NOW PART OF THEIR CAPA SYSTEM, AND THEY WILL CONTINUE TO MONITOR THAT SYSTEM FOR ANY INDICATION OF REPEATABLE REPORTS BY COMPLAINT TYPE AND BY PRODUCT NUMBER. CAPA TAKEN: ACCORDING TO (B)(4), THERE IS NO EVIDENCE TO INDICATE A MANUFACTURING ERROR OCCURRED. OCCASIONAL ALLERGIC REACTIONS HAVE BEEN NOTED TO PRODUCTS CONTAINING SILICONE ADHESIVES; PRODUCT LOT NUMBER IS NOT RETRIEVABLE. ADDITIONAL QUALITY INFORMATION PROVIDED ON (B)(4) 2014 IS AS FOLLOWS: (B)(4) SIMILAR COMPLAINT RECORDS WERE FOUND FOR IRRITATION FROM THE ADHESIVE. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED FOR THE DATE CONVATEC BECAME AWARE. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PATIENT DEVELOPED RASH/ALLERGIC REACTION TO THE SILICONE ADHESIVE BORDER OF AQUACEL FOAM ADHESIVE WHICH WAS USED FOR AN SACRAL BEDSORE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL DATED (B)(4) 2014 STATED THAT "WHEN THE REPORTING CARE GIVER DISCOVERED THE RASH , SHE STOPPED USAGE OF AQUACEL FOAM ADHESIVE, AND SWITCHED TO A COMPETITOR PRODUCT WHICH LED TO A SOOTHING OF THE AFFECTED SKIN AREA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375966 AQUACEL FOAM HYDROPHILIC WOUND DRESSING 79 NAC NAC CONVATEC INC 420680 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention