MAUDE Adverse Event Report: ETHICON INC. SISTEMA DE SUSPENSAO TVT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 830041

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Scarring (2061); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Adverse event regarding tvt mesh implanted in 2005 submitted.Adverse event regarding prolene mesh implanted in 2005 submitted via 2210968-2020-05594.

Event Description

It was reported that the patient underwent a gynecological procedure in 2005 and mesh was implanted.On (b)(6) 2020, the patient underwent a surgical procedure for pelvic organ prolapse and a scar was found under the urethra.The surgeon opines that the scar was caused by the mesh implanted in 2005.The patient did not report any symptoms or issues related to the scarring, however, the scar and previous mesh were removed.No further information is available.

• Brand Name: SISTEMA DE SUSPENSAO TVT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10327236
• MDR Text Key: 200602681
• Report Number: 2210968-2020-05593
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2020

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 Catalogue Number: 830041
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 07/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention