BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9618003-2021-01210

    MDR report key: 12171818 · Received July 15, 2021

    Report

    Report Number
    9618003-2021-01210
    Event Type
    Injury
    Date Received
    July 15, 2021
    Date of Event
    March 1, 2021
    Report Date
    June 16, 2021
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NAME: ACTUAL PRODUCT IS UNKNOWN. THE END USER COULD ONLY PROVIDE: AQUACEL AG SURGICAL BANDAGE (CONVATEC). THE PART NUMBER, LOT NUMBER, AND PRODUCT SIZE WAS NOT PROVIDED AND COULD NOT BE CONFIRMED. BRAND NAME: L3W0900 - AQUACEL AG. COMMON DEVICE NAME: DRESSING, WOUND, DRUG. PRODUCT CODE: FRO. 510(K) NUMBER: K091034. CONTACT OFFICE ADDRESS: (B)(6). 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. FDA REGISTRATION NUMBER: REPORTING SITE: (B)(4); MANUFACTURING SITE: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE END USER HAD HER FIRST SURGERY AND WAS GIVEN CEPHALEXIN THROUGH INTRAVENOUS ROUTE FOR A TOTAL LEFT HIP PLACEMENT. SHE WAS IN THE HOSPITAL FOR 4-5 DAYS AFTER FIRST SURGERY AND WAS GIVEN INTRAVENOUS CEPHALEXIN AND ORAL RIFAMPIN. AQUACEL AG SURGICAL BANDAGE (CONVATEC) WAS APPLIED POST-SURGERY. SHE HAD PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE UPON RELEASE AND DID INTRAVENOUS INFUSIONS FOR APPROXIMATELY 6 WEEKS WITH CEPHALEXIN. THE END USER CONTINUED ORAL MEDICATIONS (RIFAMPIN) AFTER PICC LINE WAS REMOVED. THE PHYSICIAN STATED INFECTION WAS DUE TO THE AQUACEL DRESSING. IT RESULTED IN DEHYDRATION, RENAL FAILURE ETC. MILD PAIN WAS NOTICED (1ST SURGERY) WHEN DRESSING WAS ON EXCEPT SMALL AMOUNT OF ITCHING. ONCE DRESSING WAS REMOVED ON DAY 7, SHE EXPERIENCED PAIN AND THERE WAS RED SKIN IRRITATION THAT INCLUDED OPEN BLISTERS AND SWELLING. SWAB WAS DONE TO CONFIRM INFECTION. THE END USER STATED SHE KEPT THE AREA CLEAN WHILE AT HOME AND HAD A TELE VISIT ON (B)(6) 2021 WITH THE PHYSICIAN WHO REVIEWED PHOTOS OF HER HIP. AT THAT TIME, HE SAID THE SKIN LOOKED "ANGRY" BUT HE DID NOT FEEL IT WAS INFECTED. ON (B)(6) 2021, SHE REPORTED THE SKIN WAS VERY RED AND IRRITATED, OOZING FLUID AND SHE COULD HARDLY WALK. HER PHYSICIAN THEN CALLED IN ORAL ANTIBIOTICS ON (B)(6) 2021. ON (B)(6) 2021, SHE WENT TO THE EMERGENCY ROOM AND SHE WAS ADMITTED WITH INTRAVENOUS ANTIBIOTICS. ON (B)(6) 2021, SHE WAS RELEASED FROM THE HOSPITAL. ON (B)(6) 2021, SHE HAD THE SECOND SURGERY THAT CONSISTED OF REMOVAL OF THE HARDWARE, EXCEPT THE BALL. THE PHYSICIAN SAID THE INFECTION WAS NOT CAUSED BY THE HARDWARE AS INTERNALLY ALL LOOKED WELL. REPORTEDLY, SKIN IRRITATION/BLISTERING WAS ONLY ON SURFACE AND SHE WAS IN THE HOSPITAL FOR FIVE ADDITIONAL DAYS. SHE SAID SHE WAS STILL RECOVERING AND NOW IN PHYSICAL THERAPY. SHE DID NOT HAVE INFORMATION REGARDING LOT OR PART NUMBER OR ANY APPLICATION USED PRIOR TO DRESSING PLACEMENT. SHE DID NOT RECALL IF A SWAB WAS DONE. NO OTHER MEDICATIONS OR TREATMENT WAS PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071946 FRO CONVATEC DOMINICAN REPUBLIC INC

    Patients

    Seq Age Sex Outcome Treatment
    1