BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.B. PROCOMFORT REGULAR

    MDR report key: 3133895 · Received May 29, 2013

    Report

    Report Number
    8022269-2013-00042
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 14, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS AN INITIAL SUBMISSION FOR THE FIRST PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8022269-2013-00042. THE MANUFACTURER REPORT NUMBER FOR THE SECOND PRODUCT IN THIS CASE IS 8022269-2013-00043. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 05-JUN-2013. THIS IS AN INITIAL SUBMISSION FOR THE FIRST PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 8022269-2013-00042. THE MANUFACTURER REPORT NUMBER FOR THE SECOND PRODUCT IN THIS CASE IS 8022269-2013-00043. 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 FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING O.B PROCOMFORT REGULAR FOR MENSTRUATION (ROUTE-VAGINAL, FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). ON THE SAME DAY, SHE NOTICED THAT THE TAMPON LEAKED AND THEN FELL APART WHILE TRYING TO REMOVE IT. SHE STATED THAT SHE TRIED ANOTHER TAMPON AND EXPERIENCED THE SAME EVENTS AGAIN. SHE ALSO STATED THAT SHE NEVER HAD ANY PROBLEM WITH ANY TAMPONS BEFORE. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON 14-MAY-2013, FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING O.B PROCOMFORT REGULAR FOR MENSTRUATION (ROUTE-VAGINAL, FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED). ON THE SAME DAY, SHE NOTICED THAT THE TAMPON LEAKED AND THEN FELL APART WHILE TRYING TO REMOVE IT. SHE STATED THAT SHE TRIED ANOTHER TAMPON AND EXPERIENCED THE SAME EVENTS AGAIN. SHE ALSO STATED THAT SHE NEVER HAD ANY PROBLEM WITH ANY TAMPONS BEFORE. THIS REPORT HAD NO ADVERSE EVENT AND THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON 26-JUN-2013: THE CONSUMER DID NOT PROVIDE A LOT NUMBER WITH THE COMPLAINT. THE SAMPLE HAD NOT RECEIVED. A REVIEW OF THE DATA ASSOCIATED WITH THIS COMPLAINT REVEALED NO ADVERSE TRENDS. THE ONLY SIGNIFICANT CHANGE RELATED TO THIS COMPLAINT WAS THE IMPLEMENTATION OF THE BEAST TECHNOLOGIES, DESIGNED TO IMPROVE THE COHESION BETWEEN FIBERS, THEREBY IMPROVING THE INTEGRITY OF THE TAMPON AND REDUCING FIBER TUFTING. NO NONCONFORMANCE WAS RECORDED FOR DEFECTS RELATED TO THIS COMPLAINT. NO SIGNIFICANT PRODUCT CHANGES RELATED TO THIS COMPLAINT WERE MADE. BASED ON THE INVESTIGATION RESULTS, NO ASSIGNABLE CAUSE WAS IDENTIFIED. COMPLAINT TRENDS WOULD CONTINUE TO BE MONITORED. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236846 O.B. PROCOMFORT REGULAR TAMPON HEB MONTREAL SAN PRO 8004550900 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1