BEUDAMED
    FDA Adverse Event Other Summary report: N

    "TRAINOR" GEL ANKLE STIRRUP

    MDR report key: 28373 · Received March 8, 1995

    Report

    Report Number
    28373
    Event Type
    Other
    Date Received
    March 8, 1995
    Date of Event
    February 21, 1995
    Report Date
    February 24, 1995
    Manufacturer
    BROWN MED INDUSTRY
    Product Code
    FYH
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Description of Event or Problem · 1

    PT WAS PROVIDED WITH AN "TRAINOR" GILL ANKLE STIRRUP SPLINT ON 2/13/95 AFTER HER SHORT LEG CAST WAS REMOVED S/P FRACTURE. PT AMBULATED WITH PT AND WORE SPLINT WITHOUT PROBLEMS UNTIL SESSION ON 2/21/95. PT CHECKED SKIN INTEGRITY AS PART OF NORMAL RX. PT FOUND THAT THE GEL PADS AROUND BOTH MALLEOLI ON RIGHT ANKLE HAD SOLIDIFIED AND CRACKED, CAUSING INCREASED PRESSURE OVER THESE BONEY PROMINENCES. SKIN BREAKDOWN WAS NOTED OVER MEDICAL MALLEOLUS AND REDNESS FROM INCREASED PRESSURE NOTED OVER LATERAL MALLEOLUS. PT REMOVED SPLINT, REPORTED INCIDENT TO DON, ADON, ADMINISTRATOR, AND ORTHOPEDIST. PT RETURNED SPLINT TO ORTHOPEDIST TO SHOW AS EVIDENCE TO THE SALES REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 "TRAINOR" GEL ANKLE STIRRUP STIRRUP ANKLE SPLINT FYH BROWN MED INDUSTRY

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other