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

Model Number 810081

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

Patient Problems Fatigue (1849); Unspecified Infection (1930); Pain (1994); Urinary Tract Infection (2120); Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/10/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Graves disease, hashimoto's disease.Device not returned.  a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.  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 a patient underwent a sling procedure on (b)(6) 2015 and the mesh was implanted.It was reported that after the sling implant, the patient needed a catheter for the week.The patient had multiple uts's.It was also reported that less than a year afterwards the patient was diagnosed with graves disease after initially being diagnosed with hashimoto's.It was reported that the patient symptoms were weight gain, lethargy, and hair loss.It was also reported that over the years the patient had various vaginal and urinary tract infections.It was reported that the patient had back, leg and hip pain, stomach cramps and lethargy.Most recently the patient has been on antibiotics for 6 months with constant uti's.No further information is available.

• Brand Name: GYNECARE TVT OBTURATOR
• 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: 11609798
• MDR Text Key: 243918676
• Report Number: 2210968-2021-02992
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 10705031000346
• UDI-Public: 10705031000346
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2021

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: 08/31/2015
• Device Model Number: 810081
• Device Catalogue Number: 810081
• Device Lot Number: 3803799
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 04/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention