BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMSOFT® INSERT FEMALE URETHRAL INSERT

    MDR report key: 7410045 · Received April 9, 2018

    Report

    Report Number
    1018233-2018-01138
    Event Type
    Injury
    Date Received
    April 9, 2018
    Date of Event
    March 14, 2018
    Report Date
    April 26, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    OCK
    UDI-DI
    00801741011115
    PMA / PMN Number
    P990002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS UNCONFIRMED. TWO UNOPENED FEMSOFT INSERTS WERE RECEIVED FOR EVALUATION. THE VISUAL INSPECTION OF THE PACKAGE NOTED NO OBVIOUS DEFECTS. UPON OPENING BOTH PACKAGES, INSERTS APPEAR TO BE IN SUITABLE CONDITION WITH LUBE PRESENT IN THE APPROPRIATE CAVITY. INSERTS WERE FILLED WITH WHAT APPEARED TO BE MINERAL OIL AND EXTERIOR OF INSERT APPEARED TO BE SLIGHTLY LUBRICATED AND SLIPPERY. BOTH SAMPLES WERE WITHIN DIMENSIONAL SPECIFICATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "INFORMING WOMEN OF POTENTIAL ADVERSE EVENTS AND COMPLICATIONS. USING THE FEMSOFT INSERT AS A GUIDE, THOROUGH EXPLANATION OF ALL POTENTIAL ADVERSE EFFECT, THEIR SIGNS AND SYMPTOMS, AS WELL AS INSTRUCTIONS ON THE ACTIONS TO TAKE IF THEY OCCUR SHOULD BE GIVEN TO THE WOMEN INCLUDING: DEVICE MIGRATION- IF A WOMEN SUSPECTS THAT A DEVICE HAS MIGRATED INTO THE BLADDER SHE SHOULD FIRST VOID WITH A MODERATELY FULL BLADDER AND CHECK TO SEE IF THE DEVICE WAS EXPELLED IN THE URINE. IF NOT, SHE SHOULD CONTACT HER PHYSICIANS."

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT IS UNCONFIRMED. TWO UNOPENED FEMSOFT INSERTS WERE RECEIVED FOR EVALUATION. THE VISUAL INSPECTION OF THE PACKAGE NOTED NO OBVIOUS DEFECTS. UPON OPENING BOTH PACKAGES, INSERTS APPEAR TO BE IN SUITABLE CONDITION WITH LUBE PRESENT IN THE APPROPRIATE CAVITY. INSERTS WERE FILLED WITH WHAT APPEARED TO BE MINERAL OIL AND EXTERIOR OF INSERT APPEARED TO BE SLIGHTLY LUBRICATED AND SLIPPERY. BOTH SAMPLES WERE WITHIN DIMENSIONAL SPECIFICATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "INFORMING WOMEN OF POTENTIAL ADVERSE EVENTS AND COMPLICATIONS USING THE FEMSOFT INSERT AS A GUIDE, THOROUGH EXPLANATION OF ALL POTENTIAL ADVERSE EFFECT, THEIR SIGNS AND SYMPTOMS, AS WELL AS INSTRUCTIONS ON THE ACTIONS TO TAKE IF THEY OCCUR SHOULD BE GIVEN TO THE WOMEN INCLUDING: DEVICE MIGRATION- IF A WOMEN SUSPECTS THAT A DEVICE HAS MIGRATED INTO THE BLADDER SHE SHOULD FIRST VOID WITH A MODERATELY FULL BLADDER AND CHECK TO SEE IF THE DEVICE WAS EXPELLED IN THE URINE. IF NOT, SHE SHOULD CONTACT HER PHYSICIANS." CORRECTION: H6 H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FEMSOFT DEVICE COULD NOT BE LOCATED FOR REMOVAL. THE COMPLAINANT STATED THAT SHE INSERTED THE DEVICE ON (B)(6) 2018, BUT NOTICED THAT IT FELT UNCOMFORTABLE SHORTLY AFTER PLACEMENT. TWO HOURS LATER, SHE DECIDED TO REMOVE THE DEVICE BUT COULD NOT GRASP IT FOR REMOVAL. SHE ALSO REPORTED THAT SHE IS AN EXPERIENCED USER WITH THIS DEVICE AND HAS BEEN USING IT FOR SEVERAL YEARS WITHOUT ANY PREVIOUS ISSUES. ON THE FOLLOWING DAY, 03/15/2018, SHE VISITED HER DOCTOR¿S OFFICE WHO RECOMMENDED THAT SHE GO TO THE EMERGENCY ROOM AS A CONCERN THAT THE DEVICE MAY STILL BE INSIDE OF HER. UPON ARRIVAL, THE HOSPITAL DECIDED TO ADMIT HER SO THAT THEY COULD RUN FURTHER TESTS TO LOCATE THE DEVICE. A PELVIC X-RAY WAS PERFORMED WHICH REVEALED NEGATIVE RESULTS. HOWEVER; A CT SCAN OF HER ABDOMEN/PELVIS WAS PERFORMED ON 03/16/2018 WHICH DID REVEAL A FOREIGN OBJECT. THE UROLOGIST THEN PERFORMED A PROCEDURE THROUGH HER URETHRA TO REMOVE THE DEVICE AND SHE WAS LATER DISCHARGED FROM THE HOSPITAL. RECORDS INDICATE THAT THIS PRODUCT WAS LAST SOLD TO THE COMPLAINANT ON (B)(6) 2014. BASED ON DOCUMENT # BM-OBS-0003 REV. 3, THE PRODUCT HAS BEEN DISCONTINUED AND HAS NOT BEEN MANUFACTURED SINCE THE ACQUISITION OF ROCHESTER MEDICAL BY C.R. BARD, WHICH OCCURRED IN NOVEMBER 2013.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FEMSOFT DEVICE COULD NOT BE LOCATED FOR REMOVAL. THE COMPLAINANT STATED THAT SHE INSERTED THE DEVICE ON (B)(6) 2018, BUT NOTICED THAT IT FELT UNCOMFORTABLE SHORTLY AFTER PLACEMENT. TWO HOURS LATER, SHE DECIDED TO REMOVE THE DEVICE BUT COULD NOT GRASP IT FOR REMOVAL. SHE ALSO REPORTED THAT SHE IS AN EXPERIENCED USER WITH THIS DEVICE AND HAS BEEN USING IT FOR SEVERAL YEARS WITHOUT ANY PREVIOUS ISSUES. ON THE FOLLOWING DAY, (B)(6) 2018, SHE VISITED HER DOCTOR¿S OFFICE WHO RECOMMENDED THAT SHE GO TO THE EMERGENCY ROOM AS A CONCERN THAT THE DEVICE MAY STILL BE INSIDE OF HER. UPON ARRIVAL, THE HOSPITAL DECIDED TO ADMIT HER SO THAT THEY COULD RUN FURTHER TESTS TO LOCATE THE DEVICE. A PELVIC X-RAY WAS PERFORMED WHICH REVEALED NEGATIVE RESULTS. HOWEVER; A CT SCAN OF HER ABDOMEN/PELVIS WAS PERFORMED ON (B)(6) 2018 WHICH DID REVEAL A FOREIGN OBJECT. THE UROLOGIST THEN PERFORMED A PROCEDURE THROUGH HER URETHRA TO REMOVE THE DEVICE AND SHE WAS LATER DISCHARGED FROM THE HOSPITAL. RECORDS INDICATE THAT THIS PRODUCT WAS LAST SOLD TO THE COMPLAINANT ON 09/05/2014. BASED ON DOCUMENT # BM-OBS-0003 REV. 3, THE PRODUCT HAS BEEN DISCONTINUED AND HAS NOT BEEN MANUFACTURED SINCE THE ACQUISITION OF ROCHESTER MEDICAL BY C.R. BARD, WHICH OCCURRED IN NOVEMBER 2013.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FEMSOFT DEVICE COULD NOT BE LOCATED FOR REMOVAL. THE COMPLAINANT STATED THAT SHE INSERTED THE DEVICE ON (B)(6) 2018, BUT NOTICED THAT IT FELT UNCOMFORTABLE SHORTLY AFTER PLACEMENT. TWO HOURS LATER, SHE DECIDED TO REMOVE THE DEVICE BUT COULD NOT GRASP IT FOR REMOVAL. SHE ALSO REPORTED THAT SHE IS AN EXPERIENCED USER WITH THIS DEVICE AND HAS BEEN USING IT FOR SEVERAL YEARS WITHOUT ANY PREVIOUS ISSUES. ON THE FOLLOWING DAY, (B)(6) 2018, SHE VISITED HER DOCTOR¿S OFFICE WHO RECOMMENDED THAT SHE GO TO THE EMERGENCY ROOM AS A CONCERN THAT THE DEVICE MAY STILL BE INSIDE OF HER. UPON ARRIVAL, THE HOSPITAL DECIDED TO ADMIT HER SO THAT THEY COULD RUN FURTHER TESTS TO LOCATE THE DEVICE. A PELVIC X-RAY WAS PERFORMED WHICH REVEALED NEGATIVE RESULTS. HOWEVER; A CT SCAN OF HER ABDOMEN/PELVIS WAS PERFORMED ON (B)(6) 2018 WHICH DID REVEAL A FOREIGN OBJECT. THE UROLOGIST THEN PERFORMED A PROCEDURE THROUGH HER URETHRA TO REMOVE THE DEVICE AND SHE WAS LATER DISCHARGED FROM THE HOSPITAL. RECORDS INDICATE THAT THIS PRODUCT WAS LAST SOLD TO THE COMPLAINANT ON (B)(6) 2014. BASED ON DOCUMENT # (B)(4), THE PRODUCT HAS BEEN DISCONTINUED AND HAS NOT BEEN MANUFACTURED SINCE THE ACQUISITION OF (B)(6) MEDICAL BY C.R. BARD, WHICH OCCURRED IN (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249033 FEMSOFT® INSERT FEMALE URETHRAL INSERT FEMSOFT INSERT OCK C.R. BARD, INC. (COVINGTON) -1018233 72203 53500824 00801741011115

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R