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 Urinary Tract Infection (2120); Other (for use when an appropriate patient code cannot be identified) (2200); Therapy/non-surgical treatment, additional (2519)

Event Type  Injury  

Event Description

It was reported that the patient underwent an unknown surgical procedure in 2005 and mesh was implanted.Following the procedure, the patient presented with voiding dysfunction, recurrent uti and mesh was noted within the vagina with an exposure of 1mm in the midline.The mesh is very superficial and visible beneath vaginal skin.The patient has undergone examination under anesthesia (eua) and cystoscopy and no mesh was found in the urinary tract.There has been no reported action at present.Additional information has been 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: 4960599
• MDR Text Key: 6039559
• Report Number: 2210968-2015-10634
• 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,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/14/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2015
• Initial Date FDA Received: 08/03/2015
• 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