MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT OBTURATOR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number 810081

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Pain (1994); Blurred Vision (2137); Urinary Frequency (2275); Numbness (2415); Ambulation Difficulties (2544)

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria for lot 3932091 and product code 810081.No additional information is available.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2019 and the mesh was implanted.It was reported that the patient experienced pain in the groin on both sides, and severe and continual pain in the hips that go down into the legs to the back of the knees especially of the left leg and down to the left foot with permanent numbness in the toes of the foot.It was reported that the patient's urine loss was more frequent than before the operation and sometimes uncontrollable with pain in the lower abdomen that becomes more pronounced during mixtures.It was also reported that the patient no longer has sensation when urinating.It was reported that the patient experienced pain in the lower abdomen and loss of tone in the rectum with difficulty in having a bowel movement and therefore was obliged to take laxatives frequently.It was reported that the patient finds difficulty to remain seated because the intense pain becomes intolerable more often in the left buttock.It was reported that the patient experienced a loss of physical endurance during daily walks which is no longer possible as the patient is unable to keep up with partner's distance and speed because of the pain that is present.It was reported that the patient takes pain relief medication frequently to reduce the pain that never goes away completely, and the patient had pain in the lower back that is almost constant.It was also reported that the patient experienced worse sleep with nighttime urination and difficulty falling back to sleep each time.It was reported that the patient experienced the issues daily since implantation of the device.It was also reported that the patient experienced vision problems with vision distortion lasting for about 30 minutes, and the patient never experienced these symptoms before the device was implanted before the operation.

• Brand Name: GYNECARE TVT OBTURATOR
• Type of Device: 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
• MDR Report Key: 12214680
• MDR Text Key: 263148409
• Report Number: 2210968-2021-06617
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Device Lot Number: 3932091
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention