BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE STRIP PLUS, 1/4" X 4"

    MDR report key: 12729551 · Received November 1, 2021

    Report

    Report Number
    9680091-2021-00021
    Event Type
    Injury
    Date Received
    November 1, 2021
    Date of Event
    October 31, 2021
    Report Date
    November 1, 2021
    Product Code
    FPX
    PMA / PMN Number
    K894205
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SAMPLE WAS NOT RETURNED FOR EVALUATION; HOWEVER, PICTURES WERE PROVIDED AND EVALUATED. DHR - NO ANOMALIES. FAILURE MODE IS CONFIRMED. ROOT CAUSE IS UNDETERMINED. THE POTENTIAL/POSSIBLE ROOT CAUSE IS THAT THE PRACTITIONER MAY HAVE FORCED TO REMOVE THE STRIP FROM THE SKIN AND CAUSED THE SKIN TEAR.

    Description of Event or Problem · 1

    4 OF 8 REPORTS. OTHER MFG REPORT NUMBERS: 9680091-2021-00017, 9680091-2021-00018, 9680091-2021-00019, 9680091-2021-00020, 9680091-2021-00022, 9680091-2021-00023, 9680091-2021-00024. A FACILITY REPORTED PATIENTS TREATED WITH SUTURE STRIP SUFFER FROM SKIN TEARS AND SKIN IRRITATION. NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1631658 SUTURE STRIP PLUS, 1/4" X 4" WOUND CLOSURES FPX B20103

    Patients

    Seq Age Sex Outcome Treatment
    1