MAUDE Adverse Event Report: ETHICON SARL GYNECARE TVT SECUR SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number TVTS4

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2008 and unknown mesh was implanted.It was reported that she experienced undisclosed injuries.No additional information was provided.

Manufacturer Narrative

(b)(4).It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2008 and tvt-secur was implanted.It was reported that she experienced pain, erosion of her internal bodily tissue and other injuries following the procedure.It was reported that the patient has undergone multiple surgeries and revisionary procedures.No additional information was provided.In addition, a device history review has been inserted into the file.  this review indicates that there was no quality concerns associated with the manufacturing process.

Manufacturer Narrative

(b)(4).It was reported that following insertion, the patient experienced vaginal discharges, bacterial vaginosis, urinary incontinence and frequency.

Manufacturer Narrative

(b)(4).Additional narrative: it was reported that following insertion the patient experienced infection, urinary and bowel problems, fistulae, recurrence, bleeding, neuromuscular problems, and vaginal scarring.

• Brand Name: GYNECARE TVT SECUR SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON SARL; puits-godet 20; neuchatel NJ 2000 ; SZ 2000
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel NJ 2000 ; SZ 2000
• Manufacturer Contact: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 5758197
• MDR Text Key: 48432943
• Report Number: 2210968-2016-10063
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/15/2017

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 Expiration Date: 10/31/2009
• Device Catalogue Number: TVTS4
• Device Lot Number: 3101773
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2016
• Initial Date FDA Received: 06/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/08/2016; 01/19/2017; 01/27/2017; 05/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/28/2007
• 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
• Patient Age: 37 YR