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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 Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.  .
 
Event Description
It was reported that a hole in device packaging was noted and was not sterile. There were no adverse patient consequences reported. No additional information was provided.
 
Manufacturer Narrative
The device was returned for analysis. During the visual inspection of opened foil, showed excessive manipulation and a hole was noted of right side near of label on the top foil; consistent with excessive manipulation. Also, in the visual inspection of the mesh no defects or damage were observed. Due to that the sample was received open and with excessive manipulation, no conclusion could be reached.
 
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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 Key7606163
MDR Text Key111324957
Report Number2210968-2018-73502
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K060713
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 05/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Catalogue NumberPCDM1
Device Lot NumberLJG352
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/04/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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