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

Catalog Number TVTS4

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Micturition Urgency (1871); Pain (1994); Scarring (2061); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2007 and a mesh was implanted.It was reported that the patient 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 by an attorney that the patient underwent a gynecological procedure on (b)(6) 2007 and a mesh was implanted due to sui.It was reported that the patient underwent sling removal and complete urethrolysis on (b)(6) 2012, due to obstructed voiding and interstitial cystitis.It was reported that on (b)(6) 2012, the patient underwent a sling revision due to voiding dysfunction.It was reported that the patient underwent a sling revision on (b)(6) 2012, due to sling exposure and interstitial cystitis with flare.It was reported that on (b)(6) 2013, the patient underwent a sling revision due to stress urinary incontinence and sling exposure.No additional information was provided.

Manufacturer Narrative

It was reported that following insertion the patient experienced urgency, bladder spasm, vaginal bleeding.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that following insertion the patient experienced extrusion, recurrence and vaginal scarring.

• 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 0151
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20 2000 neuchatel; neuchatel ; SZ
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 5153557
• MDR Text Key: 28407896
• Report Number: 2210968-2015-15090
• 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: Followup,Followup,Followup
• Report Date: 04/21/2016

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: 05/31/2009
• Device Catalogue Number: TVTS4
• Device Lot Number: 3041482
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/01/2016; 04/06/2016; 05/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/14/2007
• 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 Age: 40 YR
• Patient Weight: 96