BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALL-FLEX ARCHING SPRING DIAPHRAGM

    MDR report key: 322210 · Received March 22, 2001

    Report

    Report Number
    2211100-2001-00010
    Event Type
    Other
    Date Received
    March 22, 2001
    Date of Event
    January 1, 1996
    Report Date
    March 6, 2001
    Manufacturer
    R.W. JOHNSON PHARM. RES. INST. USA/DIV. OF ORTHO PHARMACEUTICAL CORP.
    Product Code
    HDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTS THAT IN 1995 OR 1996 WHILE USING AN ALL-FLEX ARCHING SPRING DIAPHRAGM, PT BECAME PREGNANT THEN MISCARRIED. STATES PRIOR TO THIS EVENT, PT HAD BEEN USING THIS SAME ALL-FLEX IN BETWEEN HAVING FOUR CHILDREN. REPORTEDLY, PT ASKED THEIR PHYSICIAN IF THEY SHOULD BE RE-FITTED EACH TIME THEY HAD A CHILD, BUT WAS TOLD THEY DID NOT NEED A NEW SIZE. SUBSEQUENTLY MD HAS RE-FITTED PT AND FOUND THAT PT NEEDED A LARGER DIAPHRAGM. NO FURTHER INFO AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12709 ALL-FLEX ARCHING SPRING DIAPHRAGM DIAPHRAGM HDW R.W. JOHNSON PHARM. RES. INST. USA/DIV. OF ORTHO PHARMACEUTICAL CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other