BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LITTLE PAL STIRRUP

    MDR report key: 6877362 · Received September 19, 2017

    Report

    Report Number
    1221538-2017-00004
    Event Type
    Injury
    Date Received
    September 19, 2017
    Date of Event
    January 4, 2017
    Report Date
    August 18, 2017
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE IS EXPECTED WEAR OF THE PADS AT 5 YEARS PAST USEFUL LIFE. THE STIRRUP FUNCTIONED PROPERLY AND PASSED ALL TESTING. THE PADS WERE FLATTENED AND VISIBLY DEVOID OF CUSHIONING AND SHOULD NOT HAVE BEEN IN USE PER INSTRUCTIONS FOR USE " WARNING: TO PREVENT PATIENT AND/OR USER INJURY AND/OR EQUIPMENT DAMAGE, EXAMINE THE DEVICE FOR POTENTIAL DAMAGE OR WEAR PRIOR TO USE. DO NOT USE THE DEVICE: IF DAMAGE IS VISIBLE, IF PARTS ARE MISSING, OR IF IT DOES NOT FUNCTION AS EXPECTED."

    Additional Manufacturer Narrative · 1

    AWAITING DEVICE RETURN FOR INVESTIGATION OF ANY POSSIBLE CONTRIBUTION TO INJURY. A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CASE WAS PERFORMED IN (B)(6) 2017 ON A (B)(6) YEAR OLD MALE PATIENT USING THE LITTLE PAL STIRRUPS. PATIENT WAS IN FOR AN SWENSON PULL THROUGH AND OSTOMY CLOSURE AND THE CASE LASTED 7 HRS. PATIENT DEVELOPED COMPARTMENT SYNDROME OF LEFT LEG REQUIRING FASCIOTOMIES OF LEFT CALF, DEEP AN SUPERFICIAL COMPARTMENTS WITH APPLICATION OF A WOUND VAC. HE HAD SUPERFICIAL CLOSURES OF FASCIOTOMIES 3 DAYS LATER WITH DEBRIDEMENT AND IRRIGATION. THE PATIENT HAS MADE A FULL RECOVERY. THEY RECALL THAT THE INJURY SEEMED TO BE WHERE THE EDGE OF THE STIRRUP WOULD MEET THE CALF.

    Description of Event or Problem · 1

    THE CASE WAS PERFORMED IN (B)(6) 2017 ON A (B)(6) MALE PATIENT USING THE LITTLE PAL STIRRUPS. PATIENT WAS IN FOR AN SWENSON PULL THROUGH AND OSTOMY CLOSURE AND THE CASE LASTED 7 HOURS. PATIENT DEVELOPED COMPARTMENT SYNDROME OF LEFT LEG REQUIRING FASCIOTOMIES OF LEFT CALF, DEEP AN SUPERFICIAL COMPARTMENTS WITH APPLICATION OF A WOUND VAC. HE HAD SUPERFICIAL CLOSURES OF FASCIOTOMIES 3 DAYS LATER WITH DEBRIDEMENT AND IRRIGATION. THE PATIENT HAS MADE A FULL RECOVERY. THEY RECALL THAT THE INJURY SEEMED TO BE WHERE THE EDGE OF THE STIRRUP WOULD MEET THE CALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657555 LITTLE PAL STIRRUP STIRRUP FWZ ALLEN MEDICAL SYSTEMS, INC. A-10057-A1

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention