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

Catalog Number 810081

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

Patient Problems Bleeding (1738); Unspecified Infection (1930); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357)

Event Date 09/28/2006

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2006 and a mesh was implanted with due to pelvic organ prolapse.The patient experienced pain in pelvic region, infections, bleeding and recurring prolapse, trouble urinating, difficulty sitting or standing for prolonged periods of time, and cannot engage in sexual relations.Patient underwent additional procedures to repair the mesh, and has sustained permanent and debilitating injuries.The patient experienced erosion on (b)(6) 2014 through the urethra and bladder.No additional information was provided.

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

It was reported by an attorney that the patient underwent a gynecological procedure on (b)(6) 2006 and a mesh was implanted due to sui.It was reported that patient underwent laser lithotripsy and removal of urethral mesh on (b)(6) 2014, due to urethral erosion.It was reported that patient underwent transvaginal excision of mesh on (b)(6) 2015, due to urethral mesh erosion and pelvic pain post mesh.No additional information was provided.

Manufacturer Narrative

• 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 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: 4934009
• MDR Text Key: 6015764
• Report Number: 2210968-2015-03523
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2016

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: 05/31/2007
• Device Catalogue Number: 810081
• Device Lot Number: 2932632
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2015
• Initial Date FDA Received: 07/22/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/27/2016; 08/23/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2006
• 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: 42 YR