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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PROLENE* POLY HERNIA MESH, SURGICAL, POLYMERIC

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ETHICON INC. PROLENE* POLY HERNIA MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHSL
Device Problem Detachment Of Device Component (1104)
Patient Problems Not Applicable (3189); No Code Available (3191)
Event Date 05/01/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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. If in your possession, may we have a copy of your operative report for the revision surgery? does ethicon have your permission to contact your surgeon that performed the revision surgery, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation?.

 
Event Description

It was reported by the patient that they underwent a surgical procedure on (b)(6) 2010 and mesh was implanted. Following the procedure, the patient was having complications. The patient underwent a revision surgery to have the mesh removed and hernia repaired again. The patient was informed that the mesh was not attached and was balled up on top of the hernia. The patient reports no complications after the hernia revision surgery. Additional information has been requested.

 
Manufacturer Narrative

(b)(4). The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.  .

 
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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.- J-PAC
25 centre road
somersworth NH 03878
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7636037
MDR Text Key112282566
Report Number2210968-2018-73757
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK984220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPHSL
Device LOT Number21073-50
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 Received06/27/2018
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

Patient TREATMENT DATA
Date Received: 06/25/2018 Patient Sequence Number: 1
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