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 Incontinence (1928); Pain (1994); Scar Tissue (2060)

Event Type  Injury  

Manufacturer Narrative

This emdr represents supplemental report # 2210968-2017-30501 for previously submitted mdr number 2210968-2017-30260, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude) and are available through fda¿s mdr data files webpage, at https://www.Fda.Gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/mdr-data-files#asr.Therefore, this report does not represent a new reportable event.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.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2008 and gynemesh ps was implanted.It was reported that the patient underwent removal surgery on an unk date.It was reported that she experienced abdominal pain, pelvic relaxation, worsening prolapse and adhesions.No additional information was provided.

• 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 INC.-SAN LORENZO PR; 982 road 183 km 8.3; 00754 PR ; *
• Manufacturer Contact: elba bello ; 1000 route 202; raritan 08869
• MDR Report Key: 12785507
• MDR Text Key: 284885632
• Report Number: 2210968-2021-11162
• Device Sequence Number: 1
• Product Code: OTO
• UDI-Device Identifier: 10705031037731
• UDI-Public: 10705031037731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2021

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: 01/31/2013
• Device Model Number: GPSL
• Device Catalogue Number: GPSL
• Device Lot Number: ADB809
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2008
• 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 Age: 47 YR
• Patient Sex: Female