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U.S. Department of Health and Human Services

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

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ETHICON INC. PROCEED*SURG MESH/MULTI LYR MESH, SURGICAL, POLYMERIC Back to Search Results
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.

 
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Type of DeviceMESH, 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 Key7770718
MDR Text Key116708802
Report Number2210968-2018-75060
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK060713
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/09/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2019
Device Catalogue NumberPCDM1
Device LOT NumberLBG077
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/21/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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