BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9618003-2021-01006

    MDR report key: 11899502 · Received May 28, 2021

    Report

    Report Number
    9618003-2021-01006
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Report Date
    May 3, 2021
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER THOUGHT IT WAS THE AQUACEL AG SURGICAL DRESSING BUT WAS UNABLE TO PROVIDE THE MODEL NUMBER, LOT NUMBER OR PRODUCT SIZING INFORMATION AS THE DRESSING WAS PLACED IN THE OPERATING ROOM AND THE CUSTOMER WAS NOT PROVIDED THIS INFORMATION. D TAB - BRAND NAME - L3W0900 - AQUACEL AG. COMMON DEVICE NAME - DRESSING, WOUND, DRUG. PRODUCT CODE - FRO. PMA/510K # - K091034. (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. THIS COMPLAINT HAS BEEN EVALUATED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4)

    Description of Event or Problem · 1

    THE END USER REPORTED THAT SHE HAD SURGERY ON HER LEFT KNEE AND HAD A "ZIP LINE CLOSURE TECHNIQUE" ON (B)(6) 2021 AND 1 OUT OF A MARKET UNIT OF AQUACEL DRESSINGS WAS APPLIED AT THAT TIME IN THE OPERATION ROOM. SHE DID NOT THINK THERE WERE ANY OTHER PRODUCTS USED UNDER THE DRESSING BUT WOULD CHECK WITH HER SURGEON. THE DRESSING REMAINED IN PLACE AND ON (B)(6) 2021, THE END USER EXPERIENCED ITCHING UNDER THE DRESSING, WHICH INCREASED IN INTENSITY. ON (B)(6) 2021, SHE REMOVED THE DRESSING. THE DRESSING WAS IN PLACE FOR 14 DAYS. SHE SAW HER SURGEON ON (B)(6) 2021. SHE DID NOT APPLY ANOTHER DRESSING OF ANY KIND. SHE STATED THAT THERE WAS A CLEAR DEMARCATION OF ITCHY, RED BLISTERED PERI-WOUND SKIN UNDER THE ENTIRE DRESSING (PAD AND ADHESIVE BORDER) IN THE SHAPE OF THE DRESSING. THE AREA CONTINUED TO INCREASE IN SIZE AND WAS NOW EXTENDING BEYOND THE SIZE OF THE DRESSING. SHE STATED THAT THERE WERE 3 BLISTERS WHERE THE ZIP LINE CLOSURES CROSSED "FROM PRESSURE" OF THE ZIP LINES. ADDITIONALLY, THERE WERE MANY TINY BLISTERS AND 1 OR 2 OF THEM MIGHT HAVE BROKEN CAUSING SEEPAGE OF FLUID. SHE HAD APPLIED A SMALL AMOUNT OF OVER THE COUNTER HYDROCORTISONE TO THE AFFECTED AREA AND WAS TAKING AN ANTI-HISTAMINE AROUND THE CLOCK. THE END USER STATED THAT HER KNEE FELT GREAT AS FAR AS THE SURGERY WAS CONCERNED BUT THE ITCHINESS WAS KEEPING HER AWAKE AT NIGHT. SHE DENIED CELLULITIS. SHE STATED THAT BOTH SHE AND HER SURGEON FELT SHE WAS HAVING AN ALLERGIC REACTION TO THE AQUACEL DRESSING AND THE SURGEON TOLD HER THERE WERE COMPONENTS OF THE DRESSING "IMBEDDED" IN HER SKIN AND THIS WAS CAUSING THE CONTINUED ISSUE. SHE WAS ASKING HOW SHE COULD REMOVE THESE COMPONENTS AND IN WHAT TIME FRAME SHE WOULD EXPECT THE ISSUE TO RESOLVE. THE PATIENT WAS INSTRUCTED TO DISCONTINUE THE USE OF DRESSING. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801535 FRO CONVATEC DOMINICAN REPUBLIC INC

    Patients

    Seq Age Sex Outcome Treatment
    1