MAUDE Adverse Event Report: ETHICON INC. PROCEED*SURG MESH/MULTI LYR; MESH, SURGICAL, POLYMERIC

Catalog Number PCDJ1

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Foreign Body Reaction (1868); Not Applicable (3189)

Event Date 01/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The following information has been requested, but no information has been received.Should additional information be provided, a 3500a supplemental will be submitted: the patient demographic info: age, gender, weight, bmi at the time of index procedure.Name of index surgical procedure.The diagnosis and indication for the index surgical procedure? what were current symptoms following the index surgical procedure? what were the symptoms that lead to the diagnosis of rejection? other relevant patient history/concomitant medications.If applicable, will product be returned, return date, tracking information? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient current status?.

Event Description

It was reported that the patient underwent an unknown procedure on an unknown date and mesh was implanted.The patient presented rejection on the following postoperative day.The mesh was removed on (b)(6) 2018.Additional information will be requested.

Manufacturer Narrative

A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

(b)(4).Date sent to the fda: 03/03/2019.

• 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: 7320584
• MDR Text Key: 101732809
• Report Number: 2210968-2018-71323
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047730
• UDI-Public: 10705031047730
• Combination Product (y/n): N
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: PCDJ1
• Device Lot Number: KPG331
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention