BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.B. SUPER PLUS NON-APPLICATOR

    MDR report key: 3021897 · Received March 26, 2013

    Report

    Report Number
    8022269-2013-00028
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MONTREAL SAN PRO
    Product Code
    HEB
    PMA / PMN Number
    K990536
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS (B)(4) 2013. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2013 FROM A (B)(6) FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING O.B NON-APPLICATOR TAMPONS, VAGINALLY, ONE TAMPON, FOR MENSTRUATION (FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, SHE DEVELOPED VAGINAL INFECTION. SHE STATED THAT WHILE OPENING THE TAMPON, THE VERY TOP OF THE WRAPPER DID NOT COME OFF AND WAS NOT VISIBLE, SO, UNKNOWINGLY SHE INSERTED THAT TAMPON, AFTER WHICH A SMALL PIECE OF PLASTIC WAS STUCK INSIDE HER VAGINA DUE TO WHICH SHE DEVELOPED AN INFECTION. ACTION TAKEN WITH THE DEVICE AND OUTCOME OF THE EVENT WERE UNKNOWN. THIS REPORT WAS ASSESSED AS NON-SERIOUS. THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED AS REPORTABLE MALFUNCTION IN THE UNITED STATES.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A (B)(6) FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY AND THE CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING O.B NON-APPLICATOR TAMPONS, VAGINALLY, ONE TAMPON, FOR MENSTRUATION (FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, SHE DEVELOPED VAGINAL INFECTION. SHE STATED THAT WHILE OPENING THE TAMPON, THE VERY TOP OF THE WRAPPER DID NOT COME OFF AND WAS NOT VISIBLE, SO, UNKNOWINGLY SHE INSERTED THAT TAMPON, AFTER WHICH A SMALL PIECE OF PLASTIC WAS STUCK INSIDE HER VAGINA DUE TO WHICH SHE DEVELOPED AN INFECTION. ACTION TAKEN WITH THE DEVICE AND OUTCOME OF THE EVENT WERE UNKNOWN. THIS REPORT WAS ASSESSED AS NON-SERIOUS. THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED AS REPORTABLE MALFUNCTION IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013. LOT NUMBER WAS NOT PROVIDED AND RETURNED SAMPLE WAS NOT RECEIVED. A REVIEW OF THE HISTORY OF NON CONFORMANCES WAS CONDUCTED IN THE OB DEPARTMENT AND NO NONCONFORMANCE WAS RECORDED FOR DEFECTS RELATED TO THIS COMPLAINT. A REVIEW OF THE HISTORY OF CHANGES WAS PERFORMED AND THERE WAS NO EVIDENCE TO SUPPORT THAT THE CHANGES MADE WERE RELATED TO THIS COMPLAINT. BASED ON THE INVESTIGATION RESULTS, DUE TO LACK OF A COMPLAINT SAMPLE, DUE TO LOT NUMBER NOT PROVIDED AND TO THE ABSENCE OF ADVERSE TREND, NO ASSIGNABLE CAUSE WAS IDENTIFIED. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT REMAINS NON-SERIOUS. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123951 O.B. SUPER PLUS NON-APPLICATOR TAMPON HEB MONTREAL SAN PRO OBSPNAUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1