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

Catalog Number 830041BL

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); No Code Available (3191)

Event Date 12/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent an unknown procedure on (b)(6) 2016 and the mesh was implanted.At (b)(6) follow up, the mesh exposure was noted in a midline over incision.The patient listed for revision under general anesthesia.No further information is available.

• Brand Name: GYNECARE TVT RETROPUBIC SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON SARL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6208291
• MDR Text Key: 63368171
• Report Number: 2210968-2016-36949
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 830041BL
• Device Lot Number: 3901351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2016
• 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