BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITYHOOK

    MDR report key: 20566318 · Received October 30, 2024

    Report

    Report Number
    1216677-2024-00060
    Event Type
    Injury
    Date Received
    October 30, 2024
    Date of Event
    September 26, 2024
    Report Date
    January 8, 2025
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGE
    UDI-DI
    00888937014761
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: B4, G3, G6, H2, H3, H6, H11. DISTRIBUTION HISTORY: THE DISTRIBUTION HISTORY CANNOT BE TRACED AS NEITHER THE PRODUCT WAS RETURNED BACK, NOR THE BATCH NUMBER/LOT NUMBER INFORMATION WAS PROVIDED. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, IT SHOULD BE NOTED AT THE TIME OF MANUFACTURE RECORDS FROM EACH LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL COOPERSURGICAL QUALITY RELEASE SPECIFICATIONS. SHOULD THE COMPLAINT PRODUCT LOT NUMBER BE PROVIDED GOING FORWARD, THE DEVICE HISTORY RECORD WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED NO SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE: ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED NOR THE BATCH NUMBER/LOT NUMBER INFORMATION WAS PROVIDED. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IN NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    G2: CANADA DEVICE LOCATION IS UNKNOWN. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PARTURITION, ARTIFICIAL RUPTURE OF AMNIOTIC MEMBRANE WAS PERFORMED USING THE MITYHOOK. UPON DELIVERY, THE BABY WAS NOTED TO HAVE SCALP LACERATIONS THAT REQUIRED SUTURING TO REPAIR. NO ADDITIONAL INFORMATION IS AVAILABLE. 10035 MITYHOOK 2024-10-0000502.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2019894 MITYHOOK AMNIOTOME HGE COOPERSURGICAL, INC. 10035 UNKNOWN 00888937014761

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Required Intervention