BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1000317571-2021-00127

    MDR report key: 11502593 · Received March 17, 2021

    Report

    Report Number
    1000317571-2021-00127
    Event Type
    Injury
    Date Received
    March 17, 2021
    Report Date
    February 18, 2021
    Manufacturer
    CONVATEC LTD
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS ONLY ABLE TO PROVIDE THE PRODUCT NAME AS AQUACEL AG RIBBON DRESSING, BUT WAS UNABLE TO PROVIDE THE MODEL NUMBER, LOT NUMBER OR PRODUCT SIZING INFORMATION. BRAND NAME: AQUACEL/AQUACEL AG - ANTIMICROBIAL AG HYDROFIBER DRESSING ROPE (UNKNOWN SIZE, LOT). COMMON DEVICE NAME: DRESSING, WOUND, DRUG. PRODUCT CODE: FRO. PMA/510K #: K080383. (B)(4). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. THE EVENT IS CONSIDERED MISUSE. PER THE IFU, THE PRODUCT SHOULD BE IN USE NO LONGER THAN 7 DAYS. PER THE IFU, WHEN USING THE RIBBON IN CAVITY WOUNDS, LEAVE AT LEAST 2.5CM (1 INCH) OUTSIDE THE WOUND FOR EASY RETRIEVAL. ONLY PACK DEEP WOUNDS TO 80%, AS AQUACEL¿AG HYDROFIBER¿ RIBBON WILL EXPAND TO FILL THE WOUND SPACE ON CONTACT WITH WOUND FLUID. ALL WOUNDS SHOULD BE INSPECTED FREQUENTLY. REMOVE THE AQUACEL¿AG HYDROFIBER¿ DRESSING WHEN CLINICALLY INDICATED (I.E., LEAKAGE, EXCESSIVE BLEEDING, INCREASED PAIN) OR AFTER A MAXIMUM OF SEVEN DAYS. PER THE REPORTER, THE PRODUCT WAS LEFT INSIDE THE WOUND. 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 COMPLAINANT WAS THE ORIGINAL SURGEON, WHO REPORTED THAT THE END USER UNDERWENT A TOTAL HIP REPLACEMENT SURGERY ABOUT 2 YEARS AGO. THE END USER DEVELOPED AN INFECTION OF THE SURGICAL SITE AFTER HIS SURGERY, SO UNDERWENT A WASH OUT AND WAS THEN REFERRED FOR WOUND HEALING CENTER. THE NOTES FROM THE WOUND CENTER INCLUDE A NOTE THAT THE WOUND WAS DRESSED IN AQUACEL AG ROPE DURING AT LEAST ONE VISIT. THE WOUND DID NOT HEAL, AND THE END USER EVENTUALLY UNDERWENT A REVISION OF THE TOTAL HIP REPLACEMENT, PERFORMED BY ANOTHER SURGEON. REPORTEDLY, THE END USER WAS HOSPITALIZED. AT THAT TIME AN UNIDENTIFIED DRESSING APPROXIMATELY 2" X 3" WAS REMOVED FROM THE WOUND BED. IT WAS NOT KNOWN IF THE CONVATEC PRODUCT CONTRIBUTED TO THE INFECTION. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400303 FRO CONVATEC LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 68