MAUDE Adverse Event Report: ETHICON INC. 5MM TVT DEVICE - DISPOSABLE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 810041D

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hypersensitivity/Allergic reaction (1907); Neurological Deficit/Dysfunction (1982); Injury (2348)

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.

Event Description

It was reported that the patient underwent a gynecological procedure on (b)(6) 2004 and mesh was implanted.In (b)(6) 2017, the patient reports that she found out the mesh had damaged her urethra due to being put in too high and too tight.The patient also reports experiencing an allergic reaction, inability to urinate properly, bladder issues and worsened urge incontinence.No additional information has been reported.

• Brand Name: 5MM TVT DEVICE - DISPOSABLE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7355159
• MDR Text Key: 102968214
• Report Number: 2210968-2018-71541
• 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: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2018

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: 810041D
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/20/2018
• 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