BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RANEYSCLP CLP DSPOSE -200

    MDR report key: 15528119 · Received October 3, 2022

    Report

    Report Number
    3014334038-2022-00211
    Event Type
    Injury
    Date Received
    October 3, 2022
    Date of Event
    February 10, 2010
    Report Date
    October 21, 2022
    Manufacturer
    RAYNHAM
    Product Code
    HBO
    PMA / PMN Number
    NI
    Adverse Event
    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

    THE DISPOSABLE SCALP CLIP (ID 201037) WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 0

    A FACILITY REPORTED A DISPOSABLE SCALP CLIP (ID 201037) WAS LEFT UNDETECTED FROM A PREVIOUS SURGERY AND THE PATIENT DEVELOPED SUBDURAL INFECTION (AN ABSCESS). A SURGICAL INTERVENTION WAS PERFORMED (CRANIECTOMY) TO MITIGATE THE ISSUE.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2316118 RANEYSCLP CLP DSPOSE -200 SCALP CLIPS HBO RAYNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown