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

Catalog Number TVTRL

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Erosion (1750); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Urinary Frequency (2275)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a gynecological procedure on an unknown date and an unknown mesh was implanted.It was reported that the patient experienced unspecified complications.No additional information has been provided.

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.

Manufacturer Narrative

(b)(4).It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2011 and a 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.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

Date sent to the fda: 2/29/2016.It was reported that the patient underwent a gynecological procedure and mesh was implanted due to sui.It was reported that following insertion the patient experienced pelvic, vaginal, rectal pain, difficulty having bowel movements, total incontinence with use of urinary pads day and night, nocturia, uti¿s, erosion with two additional surgeries with excision, bladder prolapse, psychological and emotional suffering.It was reported that patient underwent bladder sling revision due to mechanical dysfunction of genitourinary device, erosion and bladder prolapse on (b)(6) 2012.It was also reported that patient had excision of vaginal due erosion vaginal and rectal pain on (b)(6) 2012.No additional information was provided.(b)(4).

Manufacturer Narrative

It was reported that following insertion the patient experienced rectocele, cystocele, and vaginal vault prolapse.

Manufacturer Narrative

Date sent to fda: 05/30/2016.It was reported that following insertion, the patient experienced frequency and inability to empty bladder.

Manufacturer Narrative

• Brand Name: GYNECARE TVT EXACT CONTINENCE 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: 4958739
• MDR Text Key: 6635121
• Report Number: 2210968-2015-10485
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2012
• Device Catalogue Number: TVTRL
• Device Lot Number: 3548276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2011
• 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: 72 YR
• Patient Weight: 64