BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RANEYSCLP CLP DSPOSE -200

    MDR report key: 15410429 · Received September 13, 2022

    Report

    Report Number
    3014334038-2022-00202
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    August 8, 2022
    Report Date
    May 10, 2023
    Manufacturer
    RAYNHAM
    Product Code
    HBO
    UDI-DI
    10381780511625
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    SCALP CLIPS ( ID- 201037) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR)- THERE IS NO INDICATION THAT THE PRODUCTION PROCESS MAY HAVE CONTRIBUTED TO THIS COMPLAINT. ALL TEST RESULTS PASSED PROCEDURAL SPECIFICATIONS. FAILURE ANALYSIS- VISUAL INSPECTION CONFIRMED THE PRESENCE OF A HAIR IN ONE OF THE PRODUCT BAGS. THE ROOT CAUSE IS UNDETERMINED AND WAS UNABLE TO BE CONFIRMED IN THE COMPLAINT EVALUATION. A DEVICE HISTORY RECORD (DHR) REVIEW AND TRENDING WERE PERFORMED AS PART OF THE EVALUATION. PROPER FINISHED GOODS TESTING WAS PERFORMED PRIOR TO RELEASE AS INDICATED IN THE DHR. PRODUCT WAS RECEIVED FOR ANALYSIS AND THE INVESTIGATION COULD CONFIRM THE COMPLAINT CONDITION.

    Description of Event or Problem · 0

    A FACILITY REPORTED THE SCALP CLIPS (ID (B)(6)) HAD A HAIR MIXED-IN, AND THE INNER BAG WAS CAUGHT IN THE SEAL PART OF THE OUTER BAG. THE PRODUCT WAS STORED IN ITS ORIGINAL POUCH. NO PATIENT INJURY/INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2756226 RANEYSCLP CLP DSPOSE -200 SCALP CLIPS HBO RAYNHAM 201037 BP607 10381780511625

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown