MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 FEMSOFT® INSERT FEMALE URETHRAL INSERT; FEMSOFT INSERT

Model Number 72203

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problems Discomfort (2330); Foreign Body In Patient (2687)

Event Date 03/14/2018

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

Event Description

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.

Manufacturer Narrative

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.".

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: FEMSOFT® INSERT FEMALE URETHRAL INSERT
• Type of Device: FEMSOFT INSERT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7410045
• MDR Text Key: 104802992
• Report Number: 1018233-2018-01138
• Device Sequence Number: 1
• Product Code: OCK
• UDI-Device Identifier: 00801741011115
• UDI-Public: (01)00801741011115
• Combination Product (y/n): N
• PMA/PMN Number: P990002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2018
• Device Model Number: 72203
• Device Catalogue Number: 72203
• Device Lot Number: 53500824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2018
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/09/2018
• Supplement Dates Manufacturer Received: 04/17/2018; 04/24/2018
• Supplement Dates FDA Received: 04/18/2018; 04/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 37