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U.S. Department of Health and Human Services

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

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ETHICON INC. PHYSIOMESH RECTANGULAR MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHY1520R
Device Problem Hole In Material (1293)
Patient Problems Adhesion(s) (1695); Pain (1994); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event Description
It was reported that a patient underwent an ipom procedure for an incisional hernia on an unknown date and mesh was implanted. After 4-5 weeks, the patient experienced violent pain which occurred after sex. The patient underwent reoperation and during the procedure it was found that half the mesh had torn and the other half adhered to the colon. The ingrown mesh part also showed adhesions. While disconnecting the mesh from the colon, the bowel was injured. Adhesiolysis with mesh explantation was performed. The explanted mesh was then sent to the pathology to examine for bacterial contamination. Another like device was used to complete the procedure. Additional information has been requested.
 
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Brand NamePHYSIOMESH RECTANGULAR
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.-GMBH
robert-koch strasse 1
norderstedt D-228 51
GM D-22851
Manufacturer Contact
guillermo villa
route 22 west po box 151
somerville, NJ 08876
9082180707
MDR Report Key5344417
MDR Text Key35073690
Report Number2210968-2016-00082
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K093932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2017
Device Catalogue NumberPHY1520R
Device Lot NumberJH8GLCC0
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 Received12/18/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/01/2015
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: 01/05/2016 Patient Sequence Number: 1
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