BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FAULTLESS DELUXE WATER BOTTLE

    MDR report key: 1164 · Received August 25, 1992

    Report

    Report Number
    1164
    Event Type
    Injury
    Date Received
    August 25, 1992
    Date of Event
    July 15, 1992
    Report Date
    August 3, 1992
    Manufacturer
    ROSS LABORATORIES
    Product Code
    FPF
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    A HOT WATER BOTTLE PURCHASED BY RESIDENT'S FAMILY AND USED ON RESIDENT'S KNEE PER RESIDENT REQUEST, WAS INVOLVED IN THIS INCIDENT. THE HOT WATER BOTTLES WERE APPLIED TO THE KNEE ON JULY 15, 1992. WHEN REMOVED, BLISTERED AREAS WERE NOTED. THESE AREAS ULTIMATELY REQUIRED ACUTE CARE HOSPITALIZATION AND DEBRIDMENTDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. 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. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAULTLESS DELUXE WATER BOTTLE FPF ROSS LABORATORIES 2814

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention