BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITYONE MUSHROOM CUP BOX OF 12

    MDR report key: 19608482 · Received June 25, 2024

    Report

    Report Number
    1216677-2024-00028
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    May 28, 2024
    Report Date
    August 15, 2024
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HDB
    UDI-DI
    00888937003123
    PMA / PMN Number
    K890307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 07/03/2023 UNDER WORK ORDER (B)(4) AND SHIPPED ON 07/19/2023. MANUFACTURING RECORD REVIEW: DHR-10067- 335530 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. 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 COOPER SURGICAL. VISUAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPER SURGICAL. 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 COOPER SURGICAL. 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. THESE ADVERSE EVENTS ARE IDENTIFIED IN THE IFU AND MAY ALSO OCCUR WHILE NAVIGATING THE PELVIS DURING DELIVERY. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    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 IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INFANT SUSTAINED DIFFUSE SCALP HYPERDENSE SWELLING IN THE LEFT TEMPOROPARIETAL AND POSTERIOR PARIETO-OCCIPITAL REGION UPON BIRTH. THE MITYONE VACUUM SYSTEM WAS USED DURING DELIVERY. INITIAL DIAGNOSIS SO FAR IS THAT THERE NO ACUTE INFARCTS OR BRAIN HEMORRHAGE. INFANT WAS ADMITTED TO THE NICU. NO ADDITIONAL INFORMATION IS AVAILABLE. 100670 MITYONE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2102672 MITYONE MUSHROOM CUP BOX OF 12 FOETAL VACUUM EXTRACTION SYSTEM CUP HDB COOPERSURGICAL, INC. 10067 335530 00888937003123

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Required Intervention| H