MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT-ABBREVO MINI LCM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number	TVTOML
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Hematuria (2558)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent a sling procedure on (b)(6) 2013 and mesh was implanted.About one year later, again urinary leakage, and urinary tract infections from (b)(6) 2015.The patient further reported the strip no longer had its effect a year after it was placed approximately, and urinary tract infections returned.In addition to external local pain at urinary meatus/clitoris level.To note, as soon as the strip is laid, horrible pains descending from the left leg to the toes not to tolerate the weight of a sheet.The patient had from the day after the pose, contact the clinic.Certainly, due to spinal anesthesia, it will last a few years had the patient been told a nerve or the spinal cord (does not remember) may have been affected, due to a repair of a few mm per year.Stop doing spinal anesthesia.Additional description for consultation on (b)(6) 2024: frequent urinary tract infections with blood**** in urine.The patient reported it takes a long time to be able to urinate, and it is always a fine spray, rarely a normal spray.After a while, the patient gets up, walks and go back to the toilet, usually ends up peeing; if waits for more than 30 minutes to go to the toilet, it's urinary tract infection assured.Urinary tract infections every 15 days since (b)(6) 2023.Green discharge without itching, at first came out of the urinary meatus then vaginal discharge - 2 negative vaginal swabs; thermal cure in (b)(6), but pain for about 2 years in the clitoris/urinary meatus; lasted 10 months continuously, very painful.These pains are regular, from a few hours to several days; they stop if antibiotic.At rest, in the evening the patient feels like heartbeat in the clitoris/meatus, as if there was an infection or at least an inflammation.Now, the patient is trying to control them, they happen she believes after urinating.If the patient gets up immediately after urinating, pain appears.So, the patient stays in the toilet, swings back and forth, and forced to pee again, by 3 to 4 new little jets arrive and in general does not have the pain.The patient has the impression that it is urine that stagnates at the bottom at the meatus or clitoris, as if there were a pouch, a supply of urine that would settle there, and that if this pouch is not emptied, it hurts.Continuous pain.For the patient, it's related to the strip, since it's too low, and bent, it may be a reserve.The sonographer of the during the translabial echo, told the patient that urinary tract infections were because of the strip because too low.The patient wonders if there be erosion of the strip to other organs, which could give blood in the urine? in (b)(6) 2024, cervical pain for about one month.Needle sensation or shooting pain in vagina on (b)(6).In (b)(6) the patient had pain in the elder on the right side and wondered if it was not the arm of the strip that hurt, left side equally but less.Ecbu done on (b)(6) and the patient takes d-mannose every day since (b)(6) to avoid urinary tract infection (femanose or umannosis).Done in (b)(6).No bladder pain in recent months.On the other hand, in (b)(6), during the green discharges, sitting in the metro, suddenly the patient had a feeling of warmth downstairs, it was surprising.The patient feared an infection related to the strip.In (b)(6) 2024, during a urinary infection escherilla coli (800,000 and 90.000), the day before, the patient had aigües joint pain in the right knee and every time the patient went to the toilet, pain in the hand and left fingers which didn't happen again.As for urine leakage, the patient only have it if they sneeze or cough or laugh.This winter on the other hand, coughing for 3 months, the patient was forced to put on real protection for urinary leaks.Current state of the patient: the strip no longer has its effect one year after its insertion and urinary tract infections have returned to 6 per year.External local pain at urinary meatus/clitoris level sometimes continuously for months, which returns from time to time, and apart from urinary tract infections.A translabial ultrasound done on (b)(6) 2024 shows a strip too low and bent.Strip that is no longer useful and causes urinary tract infections and local pain.No further information can be obtained.

• Brand Name: GYNECARE TVT-ABBREVO MINI LCM
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20856350
• Report Number: 2210968-2024-12910
• Device Sequence Number: 3918273
• Product Code: OTN
• UDI-Device Identifier: 10705031062368
• UDI-Public: (01)10705031062368(17)140531(10)3706960
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2014
• Device Catalogue Number: TVTOML
• Device Lot Number: 3706960
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown