MAUDE Adverse Event Report: ETHICON INC. GYNECARE TVT OBTURATOR W LASR; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number 810081L

Patient Problems Abdominal Pain (1685); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Discomfort (2330); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Date sent to the fda: 11/30/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: GYNECARE TVT OBTURATOR W LASR
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ
• MDR Report Key: 15859709
• MDR Text Key: 332780567
• Report Number: 2210968-2022-09770
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031062306
• UDI-Public: 10705031062306
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2012
• Device Model Number: 810081L
• Device Catalogue Number: 810081L
• Device Lot Number: 3535106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2022
• Date Device Manufactured: 05/19/2011
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female