BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9618003-2022-00003

    MDR report key: 13174374 · Received January 6, 2022

    Report

    Report Number
    9618003-2022-00003
    Event Type
    Injury
    Date Received
    January 6, 2022
    Report Date
    December 10, 2021
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT IS CONSIDERED MISUSE. PER THE IFU, THE DRESSING SHOULD NOT BE USED FOR MORE THAN 7 DAYS. THE HEALTHCARE PROFESSIONAL REPORTED THAT ISSUE HAPPENED WITH AQUACEL AG SURGICAL OR AQUACEL AG ADVANTAGE SURGICAL DRESSING - MIGHT BE 422605 BUT NOT CONFIRMED. THE COMPLAINANT WAS UNABLE TO PROVIDE THE MODEL NUMBER, LOT NUMBER OR PRODUCT SIZING INFORMATION. D TAB - BRAND NAME - L3W0900 - AQUACEL AG. COMMON DEVICE NAME - DRESSING, WOUND, DRUG. PRODUCT CODE - FRO. PMA/510K # - K091034. (B)(4). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. 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 · 0

    IT WAS REPORTED BY NURSE TO COMPANY REPRESENTATIVE THAT THE END USER WAS AN ADULT FEMALE POST CESAREAN SECTION SURGERY. THERE WAS NO IDENTIFYING INFORMATION AVAILABLE REGARDING THE CUSTOMER. THE AQUACEL AG SURGICAL OR AQUACEL AG ADVANTAGE SURGICAL DRESSING WAS APPLIED TO THE POST CESAREAN SECTION INCISION AND LEFT IN PLACE FOR TEN DAYS. THE END USER WAS DISCHARGED TO HOME WITH THE DRESSING IN PLACE. SHE RETURNED TO THE HOSPITAL ON DAY TENTH AND WHEN THE DRESSING WAS REMOVED SHE WAS FOUND TO HAVE ESCHAR ONE INCH ABOVE AND TWO-TO-THREE INCHES BELOW THE INCISION AND THESE WERE LOCATED AT THE EDGES OF THE DRESSING. THE HEALTHCARE PROFESSIONAL FELT THE REASON FOR ISSUE WAS THE DRESSING HAD BEEN STRETCHED DURING APPLICATION WHICH CAUSED BLISTERING WHICH TURNED INTO ESCHAR. NO BLISTERS WERE VISUALIZED. IT WAS FELT THAT THE DRESSING WAS APPLIED TOO TIGHTLY CAUSING AN UNDUE AMOUNT OF PRESSURE, THE TIGHTNESS OF THE DRESSING PREVENTED THE END USER FROM STANDING FULLY ERECT DUE TO DISCOMFORT FROM THE DRESSING. WHEN THE DRESSING WAS REMOVED A SLIGHT ODOR WAS NOTED. SHE WAS RE-ADMITTED TO THE HOSPITAL. SHE WAS SCHEDULED TO BE DISCHARGED TO HOME ON (B)(6) 2021. WHILE IN THE HOSPITAL SHE WAS GIVEN PRESCRIPTION ANTIBIOTIC. THE DRESSING WAS REMOVED AND DISCONTINUED AND AN ALTERNATE UNKNOWN DRESSING WAS APPLIED. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2476154 FRO CONVATEC DOMINICAN REPUBLIC INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female