BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OB PROCOMFORT SUPER E11TP04

    MDR report key: 2565194 · Received May 8, 2012

    Report

    Report Number
    2214133-2012-00280
    Event Type
    Injury
    Date Received
    May 8, 2012
    Report Date
    April 17, 2012
    Manufacturer
    SKILLMAN CONTRACT
    Product Code
    HEB
    PMA / PMN Number
    K023789
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOREIGN REPORT IS BEING SUBMITTED (B)(4) 2012, FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (OB PROCOMFORT SUPERPLUS 18S). THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL FOLLOW UP INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS FOREIGN REPORT IS BEING SUBMITTED (B)(4) 2012 FOR A DEVICE PRODUCT THAT IS CONSIDERED SAME/SIMILAR TO A US MARKETED DEVICE (OB PROCOMFORT SUPERPLUS 18S). THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL FOLLOW UP INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(4) 2012, FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM (B)(6). THE MEDICAL HISTORY OF THE CONSUMER AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING OB PROCOMFORT SUPER 16S, VAGINALLY FOR MENSTRUATION (LOT NUMBER B3141W41, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER REPORTED THAT THE CORD BROKE AND AS A RESULT THE TAMPON WAS STUCK IN VAGINA. THE CONSUMER CONSULTED A PHYSICIAN WHO REMOVED THE TAMPON. THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THE REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION). THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION IN THE UNITED STATES.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012, FROM A FEMALE CONSUMER (AGE UNSPECIFIED) REPORTING ON SELF FROM (B)(6). THE MEDICAL HISTORY OF THE CONSUMER AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING OB PROCOMFORT SUPER 16S, VAGINALLY FOR MENSTRUATION (LOT NUMBER B3141W41, FREQUENCY AND EXPIRATION DATE UNSPECIFIED). AFTER AN UNSPECIFIED DURATION, THE CONSUMER REPORTED THAT THE CORD BROKE AND AS A RESULT THE TAMPON WAS STUCK IN VAGINA. THE CONSUMER CONSULTED A PHYSICIAN WHO REMOVED THE TAMPON. THE ACTION TAKEN WITH THE DEVICE WAS UNKNOWN. THE REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION). THE COMPANY CAUSALITY WAS ASSESSED AS POSSIBLE. THIS REPORT WAS CONSIDERED A REPORTABLE MALFUNCTION IN THE UNITED STATES. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2012. DURING THE PRODUCT ANALYSIS OF THE 31 SAMPLES, NO PRODUCT DEFECT COULD BE IDENTIFIED. THE PRODUCT CHARACTERISTICS ARE IN COMPLIANCE WITH THE PRODUCT SPECIFICATION. THIS CASE REMAINS REPORTABLE MALFUNCTION IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OB PROCOMFORT SUPER E11TP04 TAMPON HEB SKILLMAN CONTRACT CPSUPE3887 B3141W41

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention