BEUDAMED
    FDA Adverse Event Other Summary report: N

    1722684-2008-00001

    MDR report key: 1020186 · Received March 10, 2008

    Report

    Report Number
    1722684-2008-00001
    Event Type
    Other
    Date Received
    March 10, 2008
    Product Code
    HDB
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE HOSP SEVERAL TIMES, BUT AS OF THE DATE OF THIS FILING HAVE NOT REC'D ANY FURTHER INFO. THE CASE IS SUSPICIOUS FOR POOR PATIENT SELECTION (FOR EXAMPLE, MOTHER WITH A HISTORY OF DIABETES, RESULTING IN A SIGNIFICANT SHOULDER DYSTOCIA). THE CT IS MOST TELLING, IT DESCRIBED EXCESSIVE CAPUT, ANOTHER CLUE THAT THIS WAS AN INFANT AT RISK PRIOR TO THE DELIVERY. ALSO, THE SUBDURAL IS DESCRIBED AT THE LEVEL OF THE CORONAL SUTURES, WHICH ARE AT THE ANTERIOR FONTANELLE, THUS MOST LIKELY A DEFLEXING APPLICATION, IF THE CUP CAUSED THE INJURY AT ALL. OUR GUIDELINES LIST THAT CEPHALOHEMATOMA IS A RISK FACTOR WHILE USING THE KIWI AND THAT APPEARS TO BE THE ONLY INJURY REQUIRING TREATMENT (PHOTOTHERAPY). THERE IS NO EVIDENCE THAT THE KIWI VACUUM DEVICE MALFUNCTIONED IN ANY WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HDB

    Patients

    Seq Age Sex Outcome Treatment
    1