BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIATECT POST-OP DRESSING WITH CHG

    MDR report key: 11164625 · Received January 13, 2021

    Report

    Report Number
    3003764829-2021-00002
    Event Type
    Injury
    Date Received
    January 13, 2021
    Date of Event
    October 15, 2020
    Report Date
    January 12, 2021
    Manufacturer
    AVERY DENNISON CORPORATION
    Product Code
    FRO
    UDI-DI
    00817138010517
    PMA / PMN Number
    K163529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AVERY DENNISON RECEIVED A COMPLAINT FROM THE OB/GYN DEPARTMENT OF A HOSPITAL IN (B)(6) THROUGH ITS DISTRIBUTOR. THE COMPLAINT INDICATED THAT SKIN REDNESS WAS OBSERVED AFTER USE OF THE RELIATECT POST-OP DRESSING WITH CHG ON A PATIENT THAT UNDERWENT A C-SECTION SURGICAL PROCEDURE. A FOLLOW-UP COMMUNICATION FROM THE HOSPITAL STATED THAT THE SKIN REDNESS EXPERIENCED BY THE PATIENT WAS MILD AND WAS TREATED WITH A TOPICAL OINTMENT. NO ADDITIONAL TREATMENT WAS REQUIRED. FURTHERMORE, NO PATIENT SENSITIVITY WAS KNOWN PRIOR TO THE USE OF THE POST-OP DRESSING CONTAINING CHG. BASED ON THE NATURE OF THE INCIDENT, RETAIN SAMPLES WERE TESTED FOR PERFORMANCE CHARACTERISTICS. ALL THE RESULTS WERE FOUND TO BE WITHIN DEVICE SPECIFICATIONS AND NO DEVICE MALFUNCTION WAS IDENTIFIED. IN ADDITION, AVERY DENNISON CONDUCTED A DEVICE HISTORY RECORD REVIEW OF THE REPORTED LOT. THE REVIEW CONFIRMED THAT THE PERFORMANCE CHARACTERISTICS WERE WITHIN SPECIFICATION AT THE TIME OF PRODUCT RELEASE.

    Description of Event or Problem · 1

    AVERY DENNISON RECEIVED A COMPLAINT FROM THE OB/GYN DEPARTMENT OF A HOSPITAL IN FLORIDA THROUGH ITS DISTRIBUTOR. THE COMPLAINT INDICATED THAT SKIN REDNESS WAS OBSERVED AFTER USE OF THE RELIATECT POST-OP DRESSING WITH CHG ON A PATIENT THAT UNDERWENT A C-SECTION SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62163 RELIATECT POST-OP DRESSING WITH CHG DRESSING, WOUND, DRUG FRO AVERY DENNISON CORPORATION 0496-0568-76 K0711A01 00817138010517

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other