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

Model Number	GPSXL3
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Urinary Frequency / Polyuria (2275); Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2013 and mesh was implanted.It was reported that the patient experienced undisclosed adverse event.No additional information was provided.
Additional Manufacturer Narrative
Date sent to fda: 4/29/2020.Corrected information: d4, h4.
Additional Manufacturer Narrative
Date sent to fda: 4/28/2020.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
Additional Manufacturer Narrative
Date sent to the fda: 09/12/2022.Additional b5 narrative: it was reported that the patient experienced urinary frequency, abnormal bleeding, pelvic pain.It was reported that the patient was diagnosed with exposed vaginal mesh on (b)(6) 2018.It was reported that the patient underwent removal surgery on (b)(6) 2018.

• Brand Name: GYNECARE GYNEMSH PS 10INX10IN
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 9987050
• Report Number: 2210968-2020-03275
• Device Sequence Number: 19922361
• Product Code: OTO
• UDI-Device Identifier: 10705031037748
• UDI-Public: 10705031037748
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K013718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/20/2020

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: 07/31/2017
• Device Model Number: GPSXL3
• Device Catalogue Number: GPSXL3
• Device Lot Number: EKE992
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 04/17/2020
• Supplement Date Received by Manufacturer: 04/28/2020; 04/29/2020; 09/12/2022
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 04/28/2020; 04/29/2020; 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female