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U.S. Department of Health and Human Services

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

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ETHICON INC. PROLENE* HERNIA SYSTEM MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHSM
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems Adhesion(s) (1695); Vomiting (2144); Obstruction/Occlusion (2422); No Code Available (3191)
Event Date 01/21/2016
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. This medwatch report is in response to receipt of maude event report number: mw5062880.
 
Event Description
It was reported that the patient underwent a hernia repair procedure on (b)(6) 2013 and mesh was implanted. In 2016, the patient reported that they became very sick and was throwing up for 10 days and had diarrhea. The patient went to the emergency room three times and it was found that the patient had a bowel obstruction. The mesh had come loose and attached to the intestine. The patient underwent reoperation on (b)(6) 2016 and a situation of the intestine was removed. The patient reported that she is currently feeling better, but still experience minor stomach issues. No additional information was provided.
 
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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)
J-PAC
25 centre rd
somersworth NH 03878
Manufacturer Contact
kenneth clark
route 22 westp o box 151
somerville, NJ 08876
9082183547
MDR Report Key5837903
MDR Text Key50899910
Report Number2210968-2016-10960
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K984220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 07/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPHSM
Device Lot NumberUNKNOWN
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 Received07/13/2016
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/01/2016 Patient Sequence Number: 1
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