BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Dressing, wound, drug

    MDR report key: 15613793 · Received October 17, 2022

    Report

    Report Number
    9618003-2022-05199
    Event Type
    Malfunction
    Date Received
    October 17, 2022
    Report Date
    September 22, 2022
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    FRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. THE PRODUCT MODEL NUMBER AND LOT NUMBER OF THE DRESSING ARE UNKNOWN. HOWEVER, THE PRODUCT NAME PROVIDED WAS AQUACEL AG ADVANTAGE SURGICAL DRESSING. BRAND NAME: L3W0900 - AQUACEL AG COMMON DEVICE NAME: DRESSING, WOUND, DRUG PRODUCT CODE: FRO 510(K) NUMBER: K091034 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: 1049092 MANUFACTURING SITE: 9618003

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. THE PRODUCT MODEL NUMBER AND LOT NUMBER OF THE DRESSING ARE UNKNOWN. HOWEVER, THE PRODUCT NAME PROVIDED WAS AQUACEL AG ADVANTAGE SURGICAL DRESSING. 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

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    THE END USER REPORTED THAT ONE DRESSING FROM UNKNOWN MARKET UNIT (MU) WAS STUCK TO HER SKIN. THE DRESSING WAS APPLIED ON HER HIP REPLACEMENT SURGERY SITE AND END USER WAS TOLD TO REMOVE IT IN SEVEN DAYS. IT WAS STATED THAT SHE FOLLOWED ALL DIRECTIONS BUT ENDED UP HAVING DIFFICULTY REMOVING THE DRESSING AND HAD A VERY ITCHY AND NASTY LOOKING, WEEPING, RED AREA ALL AROUND HER INCISION. IT WAS UNKNOWN IF ANY OTHER PRODUCTS WERE USED UNDER DRESSING PRIOR TO APPLICATION. THE END USER ALSO STATED THAT SHE TOOK A PICTURE AND SENT TO HER SURGEON'S NURSE. THE END USER AND THE DOCTOR THOUGHT SHE MIGHT BE ALLERGIC TO SOMETHING AND WAS TOLD TO TAKE ANTIHISTAMINE MEDICATION ORALLY. NO OTHER TREATMENT WAS PROVIDED. THE END USER ALSO STATED THAT SHE WILL FOLLOW UP WITH HER PRIMARY CARE PHYSICIAN (PCP). A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2386733 Dressing, wound, drug FRO CONVATEC DOMINICAN REPUBLIC INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female