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

Catalog Number 830041BL

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

Patient Problems Adhesion(s) (1695); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); 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 by a patient that she underwent a sling procedure on (b)(6) 2012.Following the procedure, the patient experienced massive pelvic and back pain, incontinence, unable to pass urine properly, kidney infections, restricted mobility, and her bladder was found to be adhered to the pubic bone.The patient was prescribed high doses of morphine.She underwent five procedures since (b)(6) 2012 in relation to the mesh and two were unsuccessful to cut the sling and remove the mesh.Additional information has been requested.

Manufacturer Narrative

(b)(4): 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 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4170032
• MDR Text Key: 5093351
• Report Number: 2210968-2014-14540
• 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,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/25/2014

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 Catalogue Number: 830041BL
• Device Lot Number: 3600991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2014
• Initial Date FDA Received: 10/14/2014
• 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