BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCEPS MCEN27-2 PEDIATRIC BACKBITER

    MDR report key: 5061593 · Received September 8, 2015

    Report

    Report Number
    2523190-2015-00076
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 19, 2015
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    KAE
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10/7/15 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - CANNOT BE COMPLETED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. UNCONFIRMED/NO RETURN OF DEVICE FOR EVALUATION DEVICE HISTORY EVALUATION - NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: NONE. VARIANCE AUTHORIZATION / DEVIATION HISTORY: NONE. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: NONE. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: ROOT CAUSE CANNOT BE DETERMINED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS THE HINGED JAW CUP BROKE OFF IN THE NASAL CAVITY DURING A SEPTOPLASTY SURGERY. (B)(6) 2015 CUSTOMER REPORTS NO HARM DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594109 FORCEPS MCEN27-2 PEDIATRIC BACKBITER PFM11 KAE INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR