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

Catalog Number PCDD1

Device Problem Delamination (2904)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.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.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Additional information was requested and the following was obtained: how was the product stored: controlled area with temps ranging from 68 ¿ 71 degrees f; was the integrity of the seal compromised: there was no evidence that the seal or packaging had been compromised.Item was taken directly from manufacturer¿s box and packaging; did the packaging look damaged: packaging was intact and uncompromised or damaged; where there any quality issues noted prior to the packaging being handled: no issues were noted prior to the opening of the packaging.

Event Description

It was reported that the patient underwent a laparoscopic umbilical hernia repair procedure on (b)(6) 2017 and the mesh was implanted.During the procedure, the mesh delaminated with layers separating.There was no evidence that the seal or packaging had been compromised.The mesh was removed and hernia was closed with suture.

Manufacturer Narrative

Actual sample was returned.There is evidence of rolling up of blood soaked orc/oxidized regenerated cellulose layer against the psm foundation, as potential cause for this delamination.Any contact of mesh device with liquids such as soaking of device in saline or other antiseptic solutions, increases the likelihood of delamination.There is no any visual indication of manufacturing related cause.A potential 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: 6440499
• MDR Text Key: 71098805
• Report Number: 2210968-2017-31401
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PCDD1
• Device Lot Number: KMG294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 03/28/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2017
• 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