MAUDE Adverse Event Report: ETHICON INC. GYNECARE GYNEMSH PS 4INX6IN; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number GPSL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Micturition Urgency (1871); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Discomfort (2330); Prolapse (2475); Dysuria (2684); Constipation (3274); 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 11/19/2003 and mesh x2 were implanted.It was reported that the patient experienced complete wall prolapse, urgency, low back pain, hip pain, abdominal pain, coccygeal pain, urine tract infections, ulcerated cystocele, dyspareunia, stress incontinence, frequency, nocturia, vaginal discomfort, groin pain, buttock pain, constipation, dysuria, urinary leakage and pelvic pain.No additional information was provided.

Manufacturer Narrative

(b)(4).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.

• Brand Name: GYNECARE GYNEMSH PS 4INX6IN
• 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 PR 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15765274
• MDR Text Key: 303390679
• Report Number: 2210968-2022-09310
• Device Sequence Number: 1
• Product Code: OTO
• UDI-Device Identifier: 20705031037738
• UDI-Public: 20705031037738
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K013718
• 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: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GPSL
• Device Catalogue Number: GPSL
• Device Lot Number: SDEQ05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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