MAUDE Adverse Event Report: ETHICON INC. ARTISYN Y-SHAPED MESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number ARTY

Device Problem Migration (4003)

Patient Problems Erosion (1750); Fistula (1862); Pain (1994); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Ethicon mdr summary reporting exemption (b)(4) reporting period april 1, 2018 through may 31, 2018 (b)(4) total number of events ¿ 35; artisyn y-shaped mesh -1 ; gynecare gynemesh ps -34 (b)(4).

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2015 and the mesh was implanted.Following the procedure, the patient experienced pain, erosion of her internal bodily tissue and vesicovaginal fistula.The patient underwent a mesh excision surgery on (b)(6) 2017.No further information is available.

Manufacturer Narrative

Pc-(b)(4).Date sent to fda: (b)(4) 2018.Ethicon mdr summary reporting exemption e2013037 reporting period (b)(4) 2018 through (b)(4) 2018.

Manufacturer Narrative

Ethicon mdr summary reporting exemption (b)(4).Reporting period june 1, 2018 through july 31, 2018.

Manufacturer Narrative

Date sent to fda: 4/24/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period june 1, 2018 through july 31, 2018.

Manufacturer Narrative

Date sent to fda: 02/11/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period june 1, 2018 through july 31, 2018.

Manufacturer Narrative

Date sent to fda: 2/18/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period june 1, 2018 through july 31, 2018.

Manufacturer Narrative

Date sent to fda: 04/20/2021.Ethicon mdr summary reporting exemption e2013037.Reporting period june 1, 2018 through july 31, 2018.

Manufacturer Narrative

Date sent to fda: 02/22/2021.Ethicon mdr summary reporting exemption e2013037.Reporting period june 1, 2018 through july 31, 2018.

• Brand Name: ARTISYN Y-SHAPED MESH
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7787917
• MDR Text Key: 117256303
• Report Number: 2210968-2018-75204
• Device Sequence Number: 1
• Product Code: OTO
• UDI-Device Identifier: 10705031218475
• UDI-Public: 10705031218475
• Combination Product (y/n): N
• PMA/PMN Number: K113205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/14/2018

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: 10/31/2015
• Device Model Number: ARTY
• Device Catalogue Number: ARTY
• Device Lot Number: GM8GGPB0
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2018
• Initial Date FDA Received: 08/16/2018
• Supplement Dates Manufacturer Received: 10/25/2018; 12/28/2018; 02/11/2019; 04/24/2019; 02/18/2020; 02/22/2021; 04/20/2021
• Supplement Dates FDA Received: 10/25/2018; 12/28/2018; 02/11/2019; 04/24/2019; 02/18/2020; 02/22/2021; 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR