BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN DISPOS PERFORATOR

    MDR report key: 8721810 · Received June 21, 2019

    Report

    Report Number
    1226348-2019-00222
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    June 14, 2019
    Report Date
    June 14, 2019
    Manufacturer
    RAYNHAM
    Product Code
    HBF
    PMA / PMN Number
    K791101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI (B)(4). THE COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN, THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. DEVICE HISTORY RECORDS (DHRS) WERE REVIEWED AND NO ANOMALIES WERE FOUND. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. COMPLAINT WILL BE CLOSED AS 'NO COMPLAINT SAMPLE RETURNED TO CODMAN FOR EVALUATION'. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON USED THE COMPLAINT PERFORATOR TO MAKE THE FOURTH BURR HOLE OUT OF FOUR. THE DURA INJURY DID NOT OCCUR, BUT THE DRILL DID NOT STOP AND IT CAME OUT. THE BONE PAD WAS NOT CONFIRMED TO BE FORMED. THE CONCOMITANT DRILL WAS A MEDTRONIC AND PERFORATION SPEED WAS 75000. THE COMPLAINT DEVICE WAS SINGLE-USED. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516270 CODMAN DISPOS PERFORATOR DISPOSABLE PERFORATORS HBF RAYNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1