MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

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

Patient Problems Adhesion(s) (1695); Bleeding (1738); Pain (1994); Other (for use when an appropriate patient code cannot be identified) (2200); Surgical procedure (2357); Treatment with medication(s) (2571)

Event Type  Injury  

Event Description

It was reported in a research article that sling procedures were performed on an unknown date.Complications included peri-operative bladder injury which was treated with a urinary catheter or abandoned procedure with conventional repair; mesh exposure which was managed by mesh excision, vaginal estrogen or no intervention; recurrent prolapse requiring re-operation; de novo prolapse; urinary dysfunction requiring surgery or medication; bowel dysfunction; bleeding which was managed conservatively; need for re-suturing; vaginal adhesions requiring division under general anesthesia; granulation tissue managed with silver nitrate or surgical excision; vaginal/groin pain managed with anti-inflammatories, topical steroids, analgesics, partial mesh excision or division of the arms of the mesh; and dyspareunia.Additional information was requested.

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.

• Brand Name: GYNECARE TVT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• 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: 4816004
• MDR Text Key: 5898485
• Report Number: 2210968-2015-06690
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K974098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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