BEUDAMED
    FDA Adverse Event Summary report: N

    ANAGO, ICE PACK

    MDR report key: 9441 · Received July 18, 1994

    Report

    Report Number
    9441
    Date Received
    July 18, 1994
    Report Date
    July 6, 1994
    Manufacturer
    ANAGO
    Product Code
    KYR
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ICE PACK LEAKED. NO INJURY/HARM TO PATIENT OCCURRED. REPORT SUBMITTED TO FDA AND USP.INVALID 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 ANAGO, ICE PACK LOADING CHUTE KYR ANAGO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Invalid Data