BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUMED

    MDR report key: 23893 · Received July 13, 1995

    Report

    Report Number
    23893
    Event Type
    Malfunction
    Date Received
    July 13, 1995
    Report Date
    July 3, 1995
    Manufacturer
    ACUMED, INC.
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    AN INSTRUMENTATION DEVICE (REAMER) TIP BROKE OFF IN PATIENT'S SITE OF SURGERY. PHYSICIAN WAS ABLE TO RETRIEVE PIECE. NO INJURY TO PATIEN.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 ACUMED CANULATED DEVICE BIT ACUMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other