BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.B NON-APPLICATOR TAMPONS

    MDR report key: 3402439 · Received October 10, 2013

    Report

    Report Number
    8022269-2013-00092
    Event Type
    Malfunction
    Date Received
    October 10, 2013
    Report Date
    September 26, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 10-OCT-2013. THIS IS AN INITIAL SUBMISSION FOR THE FIRST PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8022269-2013-00092. THE INITIAL SUBMISSION FOR THE SECOND, THIRD AND THE FOURTH PRODUCTS IN THIS CASE WILL HAVE THE MANUFACTURER REPORT NUMBER 8022269-2013-00093, 8022269-2013-00094 AND 8022269-2013-00095 RESPECTIVELY. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 11-NOV-2013. THIS IS A FOLLOW UP SUBMISSION FOR THE FIRST PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8022269-2013-00092. THE MANUFACTURER REPORT NUMBER FOR THE SECOND, THIRD AND THE FOURTH PRODUCTS ARE 8022269-2013-00093, 8022269-2013-00094 AND 8022269-2013-00095 RESPECTIVELY. 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)(6) 2013 FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING O.B NON-APPLICATOR TAMPONS, VAGINALLY, FOR MENSTRUATION (LOT NUMBER 0343M8222, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, WHEN SHE TRIED TO REMOVE THE TAMPON, THE STRINGS RIPPED OFF MAKING IT DIFFICULT AND UNSAFE TO TRY AND REMOVE. SHE EXPERIENCED THE SAME PROBLEM WITH THREE OTHER TAMPONS. SHE HAD BEEN USING OB TAMPONS FROM A LONG TIME AND NEVER HAD THIS PROBLEM BEFORE. THIS REPORT HAD NO ADVERSE EVENT AND ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED AS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2013 FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING O.B NON-APPLICATOR TAMPONS, VAGINALLY, FOR MENSTRUATION (LOT NUMBER 0343M8222, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, WHEN SHE TRIED TO REMOVE THE TAMPON, THE STRINGS RIPPED OFF MAKING IT DIFFICULT AND UNSAFE TO TRY AND REMOVE. SHE EXPERIENCED THE SAME PROBLEM WITH THREE OTHER TAMPONS. SHE HAD BEEN USING OB TAMPONS FROM A LONG TIME AND NEVER HAD THIS PROBLEM BEFORE. THIS REPORT HAD NO ADVERSE EVENT AND ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED AS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON 21-OCT-2013 THE CONSUMER DID NOT CONSULT A HEALTH CARE PROFESSIONAL. NO SAMPLE WAS RECEIVED AS OF 18-OCT-2013. A REVIEW OF THE TRENDING DATA REVEALED NO TREND FOR THE REPORTED LOT NUMBER. A REVIEW OF PRODUCT RELATED ISSUE REVEALED NO CHANGES. BATCH RECORD REVIEW REVEALED THAT THE PROCESS WAS EXECUTED AS PER ESTABLISHED PARAMETERS AND PROCEDURES. ALL IN-PROCESS CHECKS WERE PERFORMED WITH ACCEPTABLE RESULTS. NO INCIDENT IN REGARDS TO PROCESS DEVIATIONS OR ANY ATYPICAL SITUATION THAT MIGHT BE ASSOCIATED WITH THE COMPLAINT WAS OBSERVED. NO ANOMALIES WERE MET WITH THE INSPECTION OF THE RETAIN SAMPLE. DEVICE MET SPECIFICATIONS. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517728 O.B NON-APPLICATOR TAMPONS TAMPON HEB MONTREAL SAN PRO 8004132500 0343M8222

    Patients

    Seq Age Sex Outcome Treatment
    1