BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALL-FLEX ARCHING SPRING DIAPHRAGM (SILICONE

    MDR report key: 3770339 · Received March 24, 2014

    Report

    Report Number
    2242843-2014-00186
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Report Date
    March 17, 2014
    Manufacturer
    JOHNSON & JOHNSON MEDICAL BRAZIL
    Product Code
    HDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT RECEIVED FROM A PT, VIA (B)(6), THE UNITED STATES (LOCAL ID NUMBER (B)(6)). THE PT'S HEIGHT, WEIGHT, AND MEDICAL HISTORY WERE UNK. THE PT WAS PRESCRIBED AN ALL-FLEX ARCING SPRING DIAPHRAGM SILICONE ON AN UNSPECIFIED DATE. CONCOMITANT MEDICATION(S) WERE NOT REPORTED. ON AN UNK DATE, THE PT EXPERIENCED DIFFICULTLY IN REMOVING HER DIAPHRAGM. THE PT SENT AN EMAIL TO THE MEDICAL INFO GROUP IN (B)(6) STATING THAT SHE HAS "DIFFICULTY REMOVING HER ORTHO DIAPHRAGM" AND THAT HER "FINGERS ARE NOT LONG ENOUGH". SHE INQUIRED ABOUT IDENTIFYING A "TOOL AVAILABLE TO HOOK ONTO THE RIM SO THAT SHE COULD PULL IT OUT". SHE INDICATED THAT SHE HAD TRIED TO FIND SUCH A TOOL ON THE WEB TO PURCHASE, BUT WAS UNSUCCESSFUL. THE PT OUTCOME WAS UNK FOR EXPERIENCING DIFFICULTY IN REMOVING THE DIAPHRAGM. THIS REPORT WAS ASSOCIATED WITH A PRODUCT QUALITY COMPLAINT (PQC) NUMBER (PQC NUMBER (B)(4)). THIS REPORT WAS NON REPORTABLE (MALFUNCTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173375 ALL-FLEX ARCHING SPRING DIAPHRAGM (SILICONE HDW JOHNSON & JOHNSON MEDICAL BRAZIL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK