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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROCEED MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROCEED MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PCDM1
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/20/2017
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. Additional information was requested and the following was obtained: proceed mesh (pcdm1) ¿ another proceed mesh was fixed over the first mesh.
 
Manufacturer Narrative
Attempts are being 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. 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. 1. Lot #.
 
Event Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2017 and mesh was used. During the procedure, the orc layer of the mesh was getting separated during fixation. There were no adverse patient consequences reported. Additional information has been requested.
 
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Brand NamePROCEED
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer (Section G)
ETHICON GMBH
p.o. box 1409 d22841
norderstedt
GM
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key7011372
MDR Text Key106354521
Report Number2210968-2017-71062
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeIN
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 10/21/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPCDM1
Device Lot NumberLBG077
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/01/2017
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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