BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.B. COMBINATION PACKS

    MDR report key: 3151293 · Received June 7, 2013

    Report

    Report Number
    8022269-2013-00049
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MONTREAL SAN PRO
    Product Code
    HEB
    PMA / PMN Number
    K974629
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 26-JUL-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)(6) 2013, FROM A HUSBAND REPORTING ON HIS WIFE (AGE UNSPECIFIED) FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING O B COMBINATION PACKS, VAGINALLY, FOR MENSTRUATION (LOT NUMBER 3482M7897, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, WHILE REMOVING THE TAMPON FROM HER VAGINA SHE NOTICED THAT THE STRINGS OF THE TAMPONS WERE FALLING OFF. SHE HAD USED THE DEVICE IN THE PAST WITHOUT ANY ISSUES. THIS REPORT HAD NO ADVERSE EVENT AND THE 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 31-MAY-2013 FROM A HUSBAND REPORTING ON HIS WIFE (AGE UNSPECIFIED) FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING O B COMBINATION PACKS, VAGINALLY, FOR MENSTRUATION (LOT NUMBER 3482M7897, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, WHILE REMOVING THE TAMPON FROM HER VAGINA SHE NOTICED THAT THE STRINGS OF THE TAMPONS WERE FALLING OFF. SHE HAD USED THE DEVICE IN THE PAST WITHOUT ANY ISSUES. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED AS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON 17-JUL-2013. THE CONSUMER PROVIDED A LOT NUMBER WITH THE COMPLAINT WHICH WAS RELATED TO THE O.B. MULTIPACK (3482M7897). HOWEVER, IN REVIEWING THE COMPLAINT TEXT IT WAS DETERMINED THAT THE CONSUMER HAD A PROBLEM WITH THE 'SUPER' TAMPON CONTAINED WITHIN THE MULTI PACK, AND THEREFORE THE INVESTIGATION NEEDS TO BE DONE AGAINST THE 'SUPER' PRODUCT. THE MANUFACTURER HAD NOT RECEIVED A RETURNED SAMPLE AS OF 16-JUL-2013. A REVIEW OF THE DATA ASSOCIATED WITH THIS COMPLAINT REVEALED NO ADVERSE TRENDS. A MANUFACTURING AND PACKAGING 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 MAY BE ASSOCIATED TO THIS TYPE OF COMPLAINT WAS OBSERVED. A REVIEW OF PRODUCT RELATED ISSUE WAS PERFORMED AND NO CHANGES RELATED TO THIS COMPLAINT WERE MADE. THE HISTORY OF CHANGES PERFORMED ON THE PRODUCT AND PROCESS AND THE ONLY SIGNIFICANT CHANGE THAT WAS MADE TO THE STRING IS A CHANGE OF THE SUPPLIER LOCATION. RETAIN SAMPLE WAS INSPECTED AND NO ANOMALIES WERE IDENTIFIED RELATED TO THIS COMPLAINT. DEVICE MET SPECIFICATIONS. BASED ON THE INVESTIGATION RESULTS, NO ASSIGNABLE CAUSE WAS IDENTIFIED. 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
    253313 O.B. COMBINATION PACKS TAMPON HEB MONTREAL SAN PRO 8004139800 3482M7897

    Patients

    Seq Age Sex Outcome Treatment
    1