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

Catalog Number TVTS4

Device Problems Other (for use when an appropriate device code cannot be identified) (2203); Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Other (for use when an appropriate patient code cannot be identified) (2200); Stenosis (2263); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a gynecological procedure on an unknown date and an unknown mesh was implanted.It was reported that the patient experienced unspecified complications.No additional information has been provided.

Manufacturer Narrative

(b)(4).Conclusion code: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

Manufacturer Narrative

It was reported by the patient that she underwent a total hysterectomy with bilateral salpingo-oophorectomy and tumor resection in 2006 and mesh was implanted.It was reported that during the initial procedure, the patient¿s bladder was perforated.The patient experienced pain and difficulty urinating, requiring an additional procedure.In 2013, the patient was treated for dysuria with bladder cocktails applied by catheter.The patient was told her surgeon that the bladder lining was deteriorating.An exploratory laparotomy was performed in 2013 where it was found that the bladder sling had begun to deteriorate, but the surgeon did not remove the sling at this time.The patient underwent another procedure in (b)(6) 2016 to remove the sling.The patient reports she is doing better now.(b)(4) difficulty urinating.Dysuria.Additional medical intervention.Additional surgical intervention.Perforation occurred.

Manufacturer Narrative

It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2007 and tvt secur was implanted.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

(b)(4).It was reported that following insertion the patient experienced overactive bladder.Interstitial cystitis, and urethral stenosis.It was reported that patient underwent mesh excision on (b)(6) 2016 by dr.(b)(6) at (b)(6).

• 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 2000 ; SZ 2000
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 4947068
• MDR Text Key: 18715874
• Report Number: 2210968-2015-09793
• 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,consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/22/2017

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: 10/31/2008
• Device Catalogue Number: TVTS4
• Device Lot Number: 2978200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/17/2015
• Initial Date FDA Received: 07/28/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/28/2016; 02/16/2017; 05/02/2017; 05/23/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/20/2006
• 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: 50 YR