BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORO DISPOSABLE SKULL PINS

    MDR report key: 6983840 · Received October 27, 2017

    Report

    Report Number
    3003923584-2017-00049
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    October 25, 2017
    Report Date
    October 25, 2017
    Manufacturer
    PRO MED INSTRUMENTS GMBH
    Product Code
    HBL
    PMA / PMN Number
    K001808
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONL INFORMATION ARE PART OF RECALL 3003923584-10-27-2017-001-R.

    Additional Manufacturer Narrative · 1

    WE DETERMINED TO CONDUCT A RECALL OF CONCERNED PRODUCTIONS LOT.

    Description of Event or Problem · 1

    THIS IS FOLLOW-UP 01.

    Description of Event or Problem · 1

    SECOND CONACT: QM DEPARTMENT WAS CONTACTED ON (B)(4) 2017 FROM DISTRIBUTOR. DISTRIBUTOR STATED THAT THEY RECEIVED AGAIN FROM HOSPITAL THAT THEY HAVE EXPERIENCED A SECOND BREAKAGE OF THE TIP END FOR THE 3006-00 LOT# 17041. NO INJURY TO THE PATIENT IS REPORTED. FIRST CONACT: QM DEPARTMENT WAS INFORMED ON (B)(4) 2017 FROM DISTRIBUTOR ABOUT AN FIRST PIN BREAKAGE IN THE SAME FACILITY. NO PATIENT INJURY REPORTED. THIS EVENT WILL BE REPORTED WITHIN MDR 3003923584-2017-00045.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763527 DORO DISPOSABLE SKULL PINS DISPOSABLE SKULL PINS,ADULT (36PCS) HBL PRO MED INSTRUMENTS GMBH 3006-00 17041

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR