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U.S. Department of Health and Human Services

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

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ETHICON INC. MERS MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number RMS
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. Additional information was requested, and the following was obtained: was the expiration date on the individual packs of the mesh in the box? no. Can you provide pictures? attached. Sales rep. Reported that the devices were discarded, no product being returned.
 
Event Description
It was reported that prior an unknown hernia repair in 2018, there was no expiration date listed on the mesh box or individual pouch. There was no patient involvement or patient consequences reported.
 
Manufacturer Narrative
Pc-(b)(4). It was reported that this device is not malfunction reportable. Therefore, this medwatch report 2210968-2018-75496 is not reportable.
 
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Brand NameMERS MESH
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.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo PR
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7824450
MDR Text Key118548266
Report Number2210968-2018-75496
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PRE-AMEND
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRMS
Device Lot NumberJKP762
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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