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

Catalog Number GPSL34

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Pocket Erosion (2013)

Event Type  Injury  

Manufacturer Narrative

This emdr represents supplemental report # (b)(4) for previously submitted mdr number 2210968-2018-76762, subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude)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.The information included in this report was submitted outside the required timeframe due to the extended use of exemption e2013037 beyond its revoke date, as documented under (b)(4) (ethicon¿s internal reference number).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.

Event Description

Wcq received an e-mail from the ethicon risk manager team stating the following: it was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and gynemesh ps was implanted.It was reported that the patient underwent a revision surgery.It was reported that the patient experienced postmenopausal bleeding and erosion following surgery.No additional information was provided.

• Brand Name: GYNECARE GYNEMESH PS
• 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; san lorenzo PR ; *
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NH 08869
• MDR Report Key: 12824784
• MDR Text Key: 285476929
• Report Number: 2210968-2021-11576
• Device Sequence Number: 1
• Product Code: OTO
• 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: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Expiration Date: 07/31/2014
• Device Catalogue Number: GPSL34
• Initial Date Manufacturer Received: 09/27/2018
• Initial Date FDA Received: 11/16/2021
• Date Device Manufactured: 09/18/2009
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female