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 Abdominal Pain (1685); Autoimmune Disorder (1732); Diarrhea (1811); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Discomfort (2330); Prolapse (2475); Abdominal Distention (2601); Dysuria (2684); Constipation (3274); Fecal Incontinence (4571); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Date sent to the fda: 07/03/2023.To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2003 and mesh was implanted.It was reported that the patient underwent a revision surgery on (b)(6) 2007 and mesh was implanted.It was reported that the patient experienced constipation, low back pain, urine urgency, urge incontinence, nocturia, stress incontinence, vaginal discomfort, frequency, urinary tract infections, pelvic pain, rectal bleeding, cystocele, vaginal bleeding, voiding dysfunction symptoms, vaginal discharge, abdominal bloating and swelling, dysuria, leg pain, buttock pain, abdominal pain, infection, loose stools, fecal incontinence, fibromyalgia, groin pain, hip pain, hemorrhoids, atrophic vaginitis and bowel urgency.Other procedure is captured under separate file.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 07/10/2023.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SISTEMA DE SUSPENSAO TVT
• 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 ; SZ
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17253202
• MDR Text Key: 318349516
• Report Number: 2210968-2023-04787
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K012628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2007
• Device Catalogue Number: 830041
• Device Lot Number: 1010137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2002
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female