BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.B NON-APPLICATOR TAMPONS

    MDR report key: 3212261 · Received July 9, 2013

    Report

    Report Number
    8022269-2013-00052
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MONTREAL SAN PRO
    Product Code
    HEB
    PMA / PMN Number
    K990536
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 07-AUG-2013. 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.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 22-AUG-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 FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2013, THE CONSUMER STARTED USING O.B NON-APPLICATOR TAMPONS, VAGINALLY ONE TAMPON FOR FEMALE HYGIENE (LOT NUMBER 0103M7976 AND EXPIRATION DATE UNSPECIFIED). AFTER THREE HOURS, WHEN SHE TRIED TO REMOVE THE TAMPON, SOME PART OF THE TAMPON STUCK IN HER BODY AND SHE COULD NOT REACH THAT PART TO PULL IT OUT OF HER. ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THE EVENT DID NOT RESOLVE. THIS REPORT WAS ASSESSED AS NON-SERIOUS. THE COMPANY CAUSALITY WAS ASSESSED AS RELATED. 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. THE MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2013, THE CONSUMER STARTED USING O.B NON-APPLICATOR TAMPONS, VAGINALLY ONE TAMPON FOR FEMALE HYGIENE (LOT NUMBER 0103M7976 AND EXPIRATION DATE UNSPECIFIED). AFTER THREE HOURS, WHEN SHE TRIED TO REMOVE THE TAMPON, SOME PART OF THE TAMPON STUCK IN HER BODY AND SHE COULD NOT REACH THAT PART TO PULL IT OUT OF HER. ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THE EVENT DID NOT RESOLVE. THIS REPORT WAS ASSESSED AS NON-SERIOUS. THE COMPANY CAUSALITY WAS ASSESSED AS RELATED. THIS REPORT WAS CONSIDERED AS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. INITIAL SUBMITTED REPORT IS BEING RESUBMITTED TO CORRECT THE DETAILS OF EVENT. AFTER THREE HOURS, WHEN SHE TRIED TO REMOVE THE TAMPON, SHE COULD NOT REACH THE TAMPON TO PULL IT OUT OF HER AS IT WENT INSIDE HER TOO FAR AND THE ENTIRE TAMPON WAS STUCK IN HER BODY. THIS REPORT REMAINS NON-SERIOUS. THIS REPORT REMAINS 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. THE MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2013, THE CONSUMER STARTED USING O.B NON-APPLICATOR TAMPONS, VAGINALLY ONE TAMPON FOR FEMALE HYGIENE (LOT NUMBER 0103M7976 AND EXPIRATION DATE UNSPECIFIED). AFTER THREE HOURS, WHEN SHE TRIED TO REMOVE THE TAMPON, SOME PART OF THE TAMPON STUCK IN HER BODY AND SHE COULD NOT REACH THAT PART TO PULL IT OUT OF HER. ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THE EVENT DID NOT RESOLVE. THIS REPORT WAS ASSESSED AS NON-SERIOUS. THE COMPANY CAUSALITY WAS ASSESSED AS RELATED. THIS REPORT WAS CONSIDERED AS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. INITIAL SUBMITTED REPORT IS BEING RESUBMITTED TO CORRECT THE DETAILS OF EVENT. AFTER THREE HOURS, WHEN SHE TRIED TO REMOVE THE TAMPON, SHE COULD NOT REACH THE TAMPON TO PULL IT OUT OF HER AS IT WENT INSIDE HER TOO FAR AND THE ENTIRE TAMPON WAS STUCK IN HER BODY. THIS REPORT REMAINS NON-SERIOUS. THIS REPORT REMAINS A REPORTABLE MALFUNCTION CASE IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON 15-AUG-2013. THE CONSUMER PROVIDED A VALID LOT NUMBER WITH THE COMPLAINT. NO RETURNED SAMPLE WAS RECEIVED FOR EVALUATION. A REVIEW OF THE TRENDING DATA BY PRODUCT FAMILY AND SUBJECT CODES REVEALED NO UNFAVORABLE TRENDS AND NO TREND FOR THE REPORTED LOT NUMBER. 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. RETAIN SAMPLE INSPECTION CONFIRMED THAT NO NONCONFORMANCE OR MANUFACTURING DEFECTS RELATED TO THIS COMPLAINT WERE PRESENT. DEVICE MET SPECIFICATIONS. MANUFACTURING ISSUES FOR THE LOT REVEALED NO ISSUES RELATED TO THE COMPLAINT. BASED ON THE INVESTIGATION RESULTS, 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
    313453 O.B NON-APPLICATOR TAMPONS TAMPON HEB MONTREAL SAN PRO 8004134500 0103M7976

    Patients

    Seq Age Sex Outcome Treatment
    1