BEUDAMED
    FDA Adverse Event Summary report: N

    SHOWER CHAIR

    MDR report key: 627 · Received May 21, 1992

    Report

    Report Number
    627
    Date Received
    May 21, 1992
    Report Date
    May 6, 1992
    Manufacturer
    UNKNOWN
    Product Code
    FRJ
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THE ALLEDGED INCIDENT OCCURED ON APRIL 21, 1992 AND INVOLVED A PATIENT WHO RECEIVED INTERNAL BRAIN HEMORRAGING WHEN THE BACK PULLED OFF A SHOWER CHAIR AND PATIENT FELL TO FLOORINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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 SHOWER CHAIR FRJ UNKNOWN UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Invalid Data