BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RANEYSCLP CLP DSPOSE -200

    MDR report key: 21014458 · Received December 24, 2024

    Report

    Report Number
    3014334038-2024-00230
    Event Type
    Malfunction
    Date Received
    December 24, 2024
    Date of Event
    December 4, 2024
    Report Date
    April 10, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    HBO
    PMA / PMN Number
    EXEMPT
    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

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H11 THE SCALP CLIP (ID 201037) WAS NOT RETURNED FOR EVALUATION, BUT A PHOTO WAS PROVIDED: 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: A VISUAL INSPECTION CONFIRMED THE PRESENCE OF A HAIR IN ONE OF THE PRODUCT BAGS. THEREFORE, THE COMPLAINT CONDITION COULD BE CONFIRMED. ROOT CAUSE ANALYSIS: THE ROOT CAUSE IS UNDETERMINED. THE POSSIBLE ROOT CAUSE IS OPERATOR ERROR OR WORKSTATION NOT CLEAN.

    Description of Event or Problem · 0

    A FACILITY REPORTED A SCALP CLIP (B)(6) WAS CONTAMINATED WITH HAIR IN THE UNOPENED PACKAGING DURING INSPECTION. THEREFORE, THE PRODUCT WAS REMOVED FROM PROCEDURAL AREA.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85649 RANEYSCLP CLP DSPOSE -200 SCALP CLIPS HBO INTEGRA LIFESCIENCES MANSFIELD 7373610

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown