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 Pain (1994); Urinary Tract Infection (2120); Other (for use when an appropriate patient code cannot be identified) (2200); Urinary Frequency (2275); Surgical procedure (2357); Treatment with medication(s) (2571)

Event Type  Injury  

Event Description

It was reported by an attorney that a patient underwent a gynecological procedure to treat pelvic organ prolapse on (b)(6) 2008 and mesh was implanted.The patient experienced pain, urinary tract infections, erosion of her internal bodily tissue and other injuries following the procedure, and was treated with antibiotics.On (b)(6) 2008, the patient was admitted to the hospital.A cystoscopy was unremarkable with no evidence of mesh erosion into the bladder or urethra.A small area of exposed mesh was partly divided under the urethra with over-sewing of the vaginal tissues.She continued to experience frequent episodes of urinary frequency and dysuria with suprapubic and vaginal discomfort.It was reported that the patient has undergone multiple surgeries and revisionary procedures, including a mesh removal on (b)(6) 2011 and again in (b)(6) 2013.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.

• 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: ellen reuss ; route 22 west po box 151; somerville, NJ 08876 ; 9082183095
• MDR Report Key: 3583708
• MDR Text Key: 4037724
• Report Number: 2210968-2014-00507
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• 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: 12/23/2013
• 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