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 Headache (1880); Incontinence (1928); Menstrual Irregularities (1959); Pain (1994); Ambulation Difficulties (2544)

Event Date 01/08/2014

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 3723694 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) 2014 and the mesh was implanted.It was reported that the patient continued to have urinary incontinence, severe pain in pelvis and hips.It was also reported that the patient had pain during sex, pain in legs, severe decrease in walking ability, no endurance, abdominal pain, increased pms, increased bleeding during menstruation, headaches, pain on exertion, and pain in the shoulders, shoulder blades, arms, and neck.It was also reported that the patient had to have the gall bladder and fallopian tubes removed.

• 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: 12200464
• MDR Text Key: 263800126
• Report Number: 2210968-2021-06522
• 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: 07/31/2014
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Device Lot Number: 3723694
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention