BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RANEYSCLP CLP DSPOSE -200

    MDR report key: 22098391 · Received May 28, 2025

    Report

    Report Number
    3014334038-2025-00070
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    February 4, 2025
    Report Date
    November 21, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    HBO
    UDI-DI
    10381780511625
    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 CLIPS (ID 201037) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE REPORTED PRODUCT¿S LOT OR SERIAL NUMBER. NO ANOMALIES WERE IDENTIFIED THAT OCCURRED DURING THE MANUFACTURE OR PACKAGING OF THE DEVICE. FAILURE ANALYSIS - THE DEVICE APPEARED MELTED. THIS COULD BE DUE TO CUSTOMER DAMAGED OR A MANUFACTURING DEFECT. THE COMPLAINT CAN BE CONFIRMED. ROOT CAUSE ANALYSIS - POTENTIAL CAUSES INCLUDE CUSTOMER MISHANDLING OR MANUFACTURING DEFECT.

    Description of Event or Problem · 0

    A FACILITY REPORTED A PHYSICIAN NOTICED THAT THE TRACE OF ONE OF THE SCALP CLIPS (ID 201037) WAS MELTING BEFORE SURGERY. NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874769 RANEYSCLP CLP DSPOSE -200 SCALP CLIPS HBO INTEGRA LIFESCIENCES MANSFIELD 7124686 10381780511625

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown