BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALL-FLEX ARCING SPRING DIAPHRAGM

    MDR report key: 171932 · Received June 10, 1998

    Report

    Report Number
    2211100-1998-00024
    Event Type
    Injury
    Date Received
    June 10, 1998
    Date of Event
    March 6, 1998
    Report Date
    June 1, 1998
    Manufacturer
    R.W. JOHNSON PHARM. RESEARCH INSTITUTE/DIV OF ORTHO PHARMACEUTICAL CORP.
    Product Code
    HDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DIAPHRAGM NOT RETURNED.

    Description of Event or Problem · 1

    MEDICAL CHRONOLOGY RECEIVED FROM J&J LEGAL DEPARTMENT. THIS 26-YEAR-OLD WOMAN HAD USED AN ALL-FLEX ARCHING SPRING DIAPHRAGM FOR A PERIOD OF 8-12 HOURS ON 05-MAR-96. THIS WAS THE SECOND USE OF THE DIAPHRAGM. SHE WAS SEEN IN THE EMERGENCY ROOM ON 06-MAR-96 WITH VOMITING, DIARRHEA, AND FLU-LIKE SYMPTOMS. TREATMENT INCLUDED IV FLUIDS (TOTAL OF 2500 CCS), KETOROLAC TROMETHAMINE, PROMETHAZINE, HYDROCHLORIDE, MAGNESIUM SULFATE, ACETAMINOPHEN, CEFTRIAXONE SODIUM, CEFOXITIN, DOPAMINE, AND LORAZEPAM. SHE WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) WITH A DIAGNOSIS OF TOXIC SHOCK SYNDROME, AND REMAINED IN ICU FOR FOUR DAYS. PT WAS DISCHARGED, DATE UNSPECIFIED. FOLLOW-UP EXAMINATION ON 26-MAR-98 WAS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALL-FLEX ARCING SPRING DIAPHRAGM DIAPHRAGM HDW R.W. JOHNSON PHARM. RESEARCH INSTITUTE/DIV OF ORTHO PHARMACEUTICAL CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization