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

Catalog Number 810081L

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

Patient Problems Bleeding (1738); Incontinence (1928); Pain (1994); Urinary Retention (2119); Other (for use when an appropriate patient code cannot be identified) (2200); Urinary Frequency (2275); Surgical procedure (2357); Treatment with medication(s) (2571)

Event Date 06/17/2009

Event Type  Injury  

Event Description

It was reported by an attorney that a patient underwent a posterior repair and implantation of an obturator sling to treat stress incontinence on (b)(6) 2009.The patient complained of chronic persistent pelvic pain since the procedure.In (b)(6) 2010, patient was noted to have small rectocele.On (b)(6) 2010, the patient underwent further posterior repair and experienced abdominal pain, diarrhea and decreased sensation to pass urine.The patient was prescribed antibiotics.In (b)(6) 2010, the end of the mesh was palpable in the left obturator area.In (b)(6) 2011, the patient had ongoing pain, bleeding and poor urine control.In (b)(6) 2011, the patient used pain medication but complained of frequency and urgency incontinence.In 2012, the patient had pain and had episodes of twitching confined to lower limbs and perineal region.The patient experienced ongoing urinary incontinence, difficulty evacuating bowel and severe dyspareunia.On (b)(6) 2013, the mesh was removed.In (b)(6) 2013, patient¿s acute pain had been relieved but chronic ache remained and incontinence recurred.

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.

Manufacturer Narrative

(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: GYNECARE TVT OBTURATOR 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3603762
• MDR Text Key: 4067600
• Report Number: 2210968-2014-01357
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2014

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: 02/28/2010
• Device Catalogue Number: 810081L
• Device Lot Number: 3283353
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2009
• 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: 41 YR