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

Catalog Number TVTS4

Device Problem Material Erosion (1214)

Patient Problems Abscess (1690); Erosion (1750); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Retention (2119); Surgical procedure (2357)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2008 and mesh was implanted.It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was reported that the patient has undergone multiple surgeries and revisionary procedures.No additional information was provided.

Manufacturer Narrative

(b)(4).It was reported that the patient underwent mesh revision on (b)(6) 2010 and (b)(6) 2011.

Manufacturer Narrative

(b)(4).Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

(b)(4).It was reported that patient underwent a pubovaginal sling placement in (b)(6) 2009, afterwards in (b)(6) 2009 she was hospitalized for vulvar abscess with mrsa infection.

Manufacturer Narrative

It was reported that the patient underwent a gynecological procedure on (b)(6) 2008 and a mesh was implanted.It was reported that the patient underwent removal of ipg and extension, and wound irrigation and closure on (b)(6) 2014.It was reported that the patient underwent placement of ipg, programming of ipg on (b)(6) 2014 for preoperative diagnosis of intractable urgency and urge incontinence and incomplete bladder emptying.(b)(4).

• Brand Name: GYNECARE TVT SECUR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON SARL - NEUCHATEL; puits-godet 20 2000 neuchatel; neuchatel ; SZ
• Manufacturer Contact: ellen reuss ; route 22 west po box 151; somerville, NJ 08876 ; 9082183095
• MDR Report Key: 3603397
• MDR Text Key: 4090798
• Report Number: 2210968-2014-01331
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2009
• Device Catalogue Number: TVTS4
• Device Lot Number: 3066803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/23/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 59