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

Catalog Number 830041

Device Problem Material Perforation (2205)

Patient Problems Bleeding (1738); Internal Organ Perforation (1987); Pain (1994); Surgical procedure (2357)

Event Date 09/09/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent a sling procedure for the treatment of incontinence on (b)(6) 2014.On (b)(6) 2014, the patient complained of pain.An echo was performed and an accumulation of urine was found between the urinary bladder and abdominal wall.A trephination was found on the urinary bladder through a cystoscopy.Upon reoperation on (b)(6) 2014, the surgeon removed a part of the mesh and minor bleeding from the bladder was coagulated by the electric scalpel.Currently, the patient is now in stable condition and the pain has disappeared.The surgeon opined that the bladder may have been perforated by the insertion needle.

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.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• 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: 4125791
• MDR Text Key: 4796480
• Report Number: 2210968-2014-13980
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2014

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 Expiration Date: 10/31/2016
• Device Catalogue Number: 830041
• Device Lot Number: 3737368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2014
• Initial Date FDA Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2013
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention