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); Inflammation (1932); Pain (1994); Burning Sensation (2146); Depression (2361); Numbness (2415); Ambulation Difficulties (2544)

Event Date 04/23/2008

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 3065992 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 an unknown date in 2008 and the mesh was implanted.It was reported that the patient was not functional and had difficulty standing, sitting still, and a lot of burns on the hips and thighs.It was reported that the patient's groins, hips, and legs hurt.It was reported that the patient has a non-existent intimate relationship.It was reported that the patient had a small herniated disc on the scan.It was reported that the patient remained incontinent and drips upon trips to the bathroom at night.It was reported that the patient rises three to four times at night.The patient drips if the wait is too long to go to the bathroom during the day.It was reported that the patient had difficulty walking, and was diagnosed with two bursae in the buttocks and two bursae in the hips.It was reported that the patient was infiltrated without success.It was reported that the patient did physiotherapy because the pain went down to the lower legs.It was reported that the physiotherapist opined that the pain lessened as it went all the way down to the patient's thighs.It was reported that patient had problems with sciatica.It was also reported that the patient had difficulty going in and out of the car.It was also reported that the patient had difficulty sleeping and had to sleep on the back because lying on the sides were unbearable.For a short time the patient's labia majora went numb on the left and right side.The patient lost strength in the legs and had difficulty climbing the stairs.It was also reported that the patient saw a psychologist for depression.It was reported that the patient felt bad and useless with the pains because the patient was tired all the time and had not recovered.It was also reported that the patient had difficulty moving around.

• 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: 12214964
• MDR Text Key: 266057330
• Report Number: 2210968-2021-06619
• 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: 07/31/2008
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Device Lot Number: 3065992
• 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: 08/21/2007
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1