MAUDE Adverse Event Report: ETHICON INC. GYNECARE GYNEMSH PS 10INX10IN; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number	GPSXL3
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2009 and mesh was implanted and on (b)(6) 2009, perigee (ams) and apogee (ams) were implanted.It was reported that the patient underwent a revision surgery on (b)(6) 2009.It was reported that following insertion patient experienced cystocele and rectocele.It was reported that the patient experienced pain and erosion of her internal bodily tissue following the procedure.No additional information was provided.
Additional Manufacturer Narrative
Date sent to fda: 11/01/2021 this emdr represents supplemental report #2210968-2017-30710 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mdr number 2210968-2017-30260 subject of a litigation complaint summary exemption no.E2013037.The referenced exemption was revoked effective may 15, 2019.The reports previously submitted as part of the exemption were not submitted in a format compatible with the public mdr database (maude)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.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).(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.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: GYNECARE GYNEMSH PS 10INX10IN
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12728120
• Report Number: 2210968-2021-10662
• Device Sequence Number: 13813146
• Product Code: OTO
• UDI-Device Identifier: 10705031037748
• UDI-Public: 10705031037748
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K013718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/01/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2013
• Device Model Number: GPSXL3
• Device Catalogue Number: GPSXL3
• Device Lot Number: AER890
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1