MAUDE Adverse Event Report: ETHICON SARL GYNECARE TVT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL

Catalog Number TVTUNK

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

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 that the patient underwent gynecological surgical procedure on (b)(6) 2003 and tvt was implanted concurrently with cystoscopy.

Manufacturer Narrative

Date sent to fda: 6/3/2020.

• Brand Name: GYNECARE TVT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL
• Manufacturer (Section D): ETHICON SARL; puits-godet 20; neuchatel NJ 2000 ; SZ 2000
• MDR Report Key: 4958667
• MDR Text Key: 21834400
• Report Number: 2210968-2015-10468
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K974098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TVTUNK
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 99