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

Model Number 810041B

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

Patient Problems Autoimmune Disorder (1732); Headache (1880); Nausea (1970); Pain (1994); Vomiting (2144); Depression (2361); Ambulation Difficulties (2544)

Event Date 07/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(4).A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2011 and mesh was implanted.The patient reported experiencing chronic pain from 2015 to (b)(6) 2019.From 2017 to (b)(6) 2019, the patient experienced groin pain, abdominal pain, leg pain, pain in vagina/rectum, nausea, vomiting and no sex due to pain.The patient was diagnosed with fibromyalgia in 2017.Throughout 2018, the patient had to stay in bed due to pain when walking.The patient also reported an unspecified tumor on the parathyroid gland in 2015 that had to be operated on.The patient further reported experiencing shingles three times between 2015 and 2018 along with migraines and depression.No further information is available.

• Brand Name: GYNECARE TVT DEVICE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12191418
• MDR Text Key: 267749567
• Report Number: 2210968-2021-06440
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000322
• UDI-Public: 10705031000322
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2021

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 Expiration Date: 06/30/2014
• Device Model Number: 810041B
• Device Catalogue Number: 810041B
• Device Lot Number: 3540527
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2021
• Initial Date FDA Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1