MAUDE Adverse Event Report: ETHICON INC. PROCEED* MULTI-LAYER LAMINATE MESH; MESH, SURGICAL, POLYMERIC

Catalog Number PCDJ1

Device Problem Delamination (2904)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Confirm that the reported issue occurred prior to pt contact? it was reported that device supposedly detached.Are you saying that when the product was removed from the package it was falling apart or disintegrating? was the packaging that holds the device intact, including seal? were there any holes in the packaging? please confirm there was no adverse event.How was the procedure completed? what was the scheduled procedure? did you return the device for evaluation?.

Event Description

It was reported that the patient underwent an unknown procedure on (b)(6) 2017 and mesh was used.Prior to the procedure, the orc and polypropylene mesh separated when out of the package.It is unknown how the procedure was completed.There were no adverse patient consequences reported.Additional information has been requested.

Manufacturer Narrative

Additional information was requested and the following was obtained: confirm that the reported issue occurred prior to patient contact? yes.It was reported that device supposedly detached.Are you saying that when the product was removed from the package it was falling apart or disintegrating? yes according to doctor.Was the packaging that holds the device intact, including seal? yes.Were there any holes in the packaging? no.Your synergy form states that there was an adverse event yet you reported event occurred prior to patient contact.Please indicate if there was a adverse event? no.Adverse event but doctor have to search around for mesh replacement while patient still under table, it¿s happened during procedure.Luckily they found 1 composite mesh from other department.How was the procedure completed? replaced by other mesh.Did you return the device for evaluation? yes, the device was returned.

Manufacturer Narrative

Additional information: the returned mesh piece was visually examined.The defective mesh could have originated from any handling, storage, transportation and manufacturing process steps.Given the available evidence, the reported product malfunction/defect is most likely related to manufacturing process.A potential or root cause for the reported "delamination or fraying" of subject mesh device cannot be determined.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-CORNELIA; 655 ethicon circle; cornelia GA 30531
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6635555
• MDR Text Key: 77441259
• Report Number: 2210968-2017-32502
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PCDJ1
• Device Lot Number: KJG192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1