MAUDE Adverse Event Report: ETHICON INC. PROLENE* POLYPROPYLENE MESH; MESH, SURGICAL, POLYMERIC

Model Number PMII

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

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 october 1, 2018 through november 30, 2018.(b)(4).Total number of events ¿ 32.Proceed multi-layer mesh - 0.Prolene polypropylene mesh - 26.Prolene soft polypropylene mesh - 5.Ultrapro mesh - 0.Vicryl polyglactin 910 mesh ¿ 1.

Event Description

It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2010 and the mesh was implanted.Following the procedure, the patient experienced undisclosed injuries.No further information is available.

Manufacturer Narrative

Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2018 through november 30, 2018.

Manufacturer Narrative

Date sent to fda: 4/24/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2018 through november 30, 2018.

Manufacturer Narrative

Date sent to fda: 10/22/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period october 1, 2018 through november 30, 2018.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8202919
• MDR Text Key: 131619095
• Report Number: 2210968-2018-78063
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031049024
• UDI-Public: 10705031049024
• Combination Product (y/n): N
• PMA/PMN Number: K180829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/24/2018

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: 01/31/2014
• Device Model Number: PMII
• Device Catalogue Number: PMII
• Device Lot Number: BGP687
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 02/11/2019; 04/24/2019; 10/22/2020
• Supplement Dates FDA Received: 02/11/2019; 04/24/2019; 10/22/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention