BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDENT-A-BAND

    MDR report key: 5003 · Received June 11, 1993

    Report

    Report Number
    5003
    Event Type
    Injury
    Date Received
    June 11, 1993
    Date of Event
    April 21, 1993
    Report Date
    April 22, 1993
    Manufacturer
    HOLLISTER, INC.
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    AN INCIDENT OCCURRED ON APRIL 21, 1993 INVOLVING A RESZIDENT WHO SUSTAINED A LARGED LACERATION OF HER ARM. IT WAS CAUSED BY THE METAL CLASP ON THE IDENTIFICATION BAND. THE Q & A COMMITTEE MET AND DETERMINED THAT ALL SIMILAR IDENTIFICATION BRACELETS WILLBE REMOVED AS OF THIS DATE (4/22/93) AND THE DON WILL LOOK INTO FINDING ALTERNATE SAFE BANDSDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN - HUMAN FACTORS. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IDENT-A-BAND N/A HOLLISTER, INC. 6712 ADULT

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Required Intervention