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

Catalog Number 830041BL

Device Problem Material Erosion (1214)

Patient Problems Erosion (1750); Surgical procedure (2357)

Event Type  Injury  

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2012.The patient was diagnosed with erosion in (b)(6) 2015.The patient underwent a vaginal incision and excision of the edge of the tape on (b)(6) 2015.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.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

It was reported that the edge of mesh eroded through vaginal incision in the mid urethra.

• Brand Name: GYNECARE TVT RETROPUBIC 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: mary szaro ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 4788009
• MDR Text Key: 5816762
• Report Number: 2210968-2015-06198
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 830041BL
• Device Lot Number: 3642634
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/27/2012
• 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