BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTI-EMBOLISM STOCKING

    MDR report key: 33455 · Received May 2, 1996

    Report

    Report Number
    1417592-1996-03800
    Event Type
    Injury
    Date Received
    May 2, 1996
    Report Date
    May 2, 1996
    Manufacturer
    BEIRSDORF/JOBST
    Product Code
    DWL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    APPROX TWELVE PTS DEVELOPED ABRASIONS TO THE FRONT AND BACK OF LOWER HEELS WHICH REQUIRED DEBRIDEMENT PROCEDURE. THERE HAVE BEEN NO PREVIOUS INCIDENTS REPORTED AT ANY OTHER FACILITIES. THE MFR IS TRYING TO GET IN CONTACT WITH THE NURSE IN CHARGE TO DETERMINE SPECIFIC USAGE AND SIZING ISSUES. LABELING SPECIFIES APPROPRIATE MEASUREMENTS TO BE TAKEN TO ASSURE PROPER SIZE AND FIT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-EMBOLISM STOCKING ANTI-EMBOLISM STOCKING DWL BEIRSDORF/JOBST

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention