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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 PHY1515Q
Device Problems Hole In Material (1293); Appropriate Term/Code Not Available (3191)
Patient Problems Hernia (2240); No Code Available (3191)
Event Date 03/17/2016
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. Attempt is 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.
 
Event Description
It was reported that the patient underwent an unknown hernia repair procedure on unknown date and mesh was implanted. Following the procedure, on (b)(6) 2016, the patient underwent a laparoscopic ventral hernia procedure for recurrent ventral hernia. During the second procedure, when the surgeon entered the abdominal cavity, he saw where the hernia had forced its way through the center of the mesh and it split in the middle. The surgeon opined that the fixation of initial mesh was great and held firm and had great tissue integration. The procedure was completed with laying a bard ventral light mesh directly over the top of the existing mesh and fixated as the surgeon saw fit. 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
kenneth clark
route 22 westp o box 151
somerville, NJ 08876
9082183547
MDR Report Key5724175
MDR Text Key47390877
Report Number2210968-2016-09764
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 05/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPHY1515Q
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 Received05/24/2016
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: 06/14/2016 Patient Sequence Number: 1
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