MAUDE Adverse Event Report: ETHICON INC. SISTEMA DE SUSPENSAO TVT; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Catalog Number 830041

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Cyst(s) (1800); Micturition Urgency (1871); Inflammation (1932); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Dysuria (2684); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2004 and mesh was implanted.It was reported that the patient experienced urgency, frequency, incomplete voiding, nocturia, pelvic pain, back pain, abdominal pain, dyspareunia, dysuria, urinary tract infections, atrophic vaginitis, and cysts.No additional information was provided.

Manufacturer Narrative

Appropriate term / code not available (b)(4) utilized to capture incomplete voiding, nocturia, and atrophic vaginitis.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.

Manufacturer Narrative

Date sent to the fda: 11/20/2022.

• 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; neuchatel ; SZ
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15786766
• MDR Text Key: 303544420
• Report Number: 2210968-2022-09402
• 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: 11/14/2022

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: 07/31/2008
• Device Catalogue Number: 830041
• Device Lot Number: 1115241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 11/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2003
• 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