BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTC SINGLE HERNIA SUPPORT

    MDR report key: 3010968 · Received March 15, 2013

    Report

    Report Number
    1511629-2013-00001
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    August 1, 2012
    Report Date
    February 26, 2013
    Manufacturer
    SURGICAL APPLIANCE INDUSTRIES
    Product Code
    EXN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED BY PT ON (B)(4) 2013. PRODUCT TEAM ANALYZED PRODUCT ON (B)(4) 2013 AND NO EVAL COULD BE DETERMINED DUE TO PT TRIMMING AND ALTERING DEVICE.

    Description of Event or Problem · 1

    SOFT VELCRO PANEL, UNBEKNOWNST TO PT AT THE TIME, CUT ABDOMEN. IN AN EFFORT TO CONTINUE WEAR AND BEFORE PT SOUGHT CARE THE PT TRIMMED AND ALTERED THE MEDICAL DEVICE. AFTER NOT HEALING, PT SOUGHT CARE AT URGENT CARE FACILITY. PRESCRIBED MEDICATION AND WOUND HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110693 OTC SINGLE HERNIA SUPPORT NONE EXN SURGICAL APPLIANCE INDUSTRIES 2958/R-L

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention