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

Catalog Number 810041B

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

Patient Problems Rheumatoid Arthritis (1724); Diarrhea (1811); Fatigue (1849); Incontinence (1928); Inflammation (1932); Pain (1994); Skin Irritation (2076); Cramp(s) (2193); Depression (2361); Sweating (2444); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Implantation of tvtunk on unknown date was reported via medwatch report 2210968-2019-79165.

Event Description

It was reported that the patient underwent a sling procedure on (b)(6) 2010 and the mesh was implanted.It was also reported that the surgery did not correct her incontinence problem.Then the patient underwent another surgery.The patient developed food intolerance since mesh and experienced overall inflammation that flares up when eating certain foods.The patient also experienced pelvic pain, dull ache around mons pubis area regularly, buttocks bone, gut and rectal pain, fecal urgency, diarrhea almost daily, inflammation of colon, sometimes bleeding from rectum after a bad day of loose bowel movements around 7-10 times in a day, still have some incontinence, extreme fatigue, regular bouts of feeling like going to vomit, break-out in hives, sweating, rheumatoid arthritis, chronic fatigue, muscle cramps in legs and feet, problems with feet regularly where it looks like an electric pulse is running through feet and nerves/tendons twitching, depression, poor memory function and hair loss.No further information is available.

• Brand Name: GYNECARE TVT DEVICE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8379901
• MDR Text Key: 137466930
• Report Number: 2210968-2019-79164
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000322
• UDI-Public: 10705031000322
• Combination Product (y/n): N
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2019

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: 09/30/2012
• Device Catalogue Number: 810041B
• Device Lot Number: 3365720
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention