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

Catalog Number PCDM1

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts are being 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.

Event Description

It was reported that the patient underwent an unknown laparoscopic procedure on (b)(6) 2018 and mesh was used.During the procedure, the mesh got separated.A like device was used to complete the procedure.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

Pc-(b)(4).Date sent to the fda: (b)(4) 2018.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.An opened box, an empty opened foil and an opened folder with an oxidized regenerated cellulose (orc) layer and a mesh of product code (b)(4), lot # lbg077 were returned for analysis.During the visual inspection of the sample, mesh and orc layer were noted totally separated.The orc layer present body fluids and it had rolled up into a folded position and separated from the psm layer.In addition, the body fluids on the orc layer and mesh are indications of lack of sufficient stoppage of bleeding.Any contact of mesh device with liquids such as blood, or soaking in saline or other antiseptic solutions, increases the likelihood of delamination.Exposure time during contact with blood prior to completion of secured mesh placement, could contribute to separation of orc layer of mesh.The foil was reviewed and the external appearance did not present damage or defects.Seal margin was continued and no defect or damage were observed that indicate a possibility of loss of integrity.Due to the condition of the sample received, it could not be determined what may have caused the reported incident.

• 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.; 655 ethicon circle; cornelia GA 30531
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7770718
• MDR Text Key: 116708802
• Report Number: 2210968-2018-75060
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047754
• UDI-Public: 10705031047754
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: PCDM1
• Device Lot Number: LBG077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1