BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIWI VACUUM ASSISTED DELIVERY DEVICE

    MDR report key: 6062729 · Received October 27, 2016

    Report

    Report Number
    1722684-2016-00002
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Date of Event
    March 18, 2016
    Report Date
    March 19, 2016
    Manufacturer
    CLINICAL INNOVATIONS LLC
    Product Code
    HDB
    PMA / PMN Number
    K981260
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBGALEAL HEMORRHAGES ARE A RARE AND KNOWN RISK FACTOR FOR ANY VACUUM-ASSISTED VAGINAL DELIVERIES. RISK FACTORS FOR THIS TYPE OF HEMORRHAGE INCLUDE: NULLIPARITY, MALPOSITION, MISPLACEMENT OF THE CUP, PROLONGED TRACTION EFFORTS, AND POP-OFS/DETACHMENT OF THE VACUUM CUP. THE REPORT INDICATED THAT THREE POP-OFFS OCCURRED DURING THE PROCEDURE AND PER OUR INSTRUCTIONS FOR USE, IS RECOMMENDED NO MORE THAN TWO. THE INFANT WAS DISCHARGED AFTER 3 DAYS WITH NO COMPLICATIONS. DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON MARCH 31 2016, CLINICAL INNOVATIONS WAS NOTIFIED OF AN INJURY INVOLVING THE KIWI VACUUM ASSISTED DEVICE VIA EMAIL. THE REPORT INDICATES THAT ON (B)(6) 2016 A NEWBORN WAS DIAGNOSED WITH SUBGALEAL HEMATOMA FOLLOWING VAGINAL DELIVERY WITH A VACUUM ASSISTED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712278 KIWI VACUUM ASSISTED DELIVERY DEVICE VACUUM ASSITED DEILVERY DEVICE HDB CLINICAL INNOVATIONS LLC VAC-6000M

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Hospitalization