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U.S. Department of Health and Human Services

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

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ETHICON INC. PHYSIOMESH MESH, SURGICAL Back to Search Results
Lot Number UNKNOWN
Device Problem Failure To Adhere Or Bond (1031)
Patient Problems Adhesion(s) (1695); Hernia (2240)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Conclusion: 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 a hernia repair procedure on an unknown date and mesh was implanted using absorbatack for fixation. The mesh fell off into abdominal cavity and adhered to bowel loop. The professor opines that the fixation device was not compatible to the mesh and believes this was a result of mesh fixation problem.
 
Manufacturer Narrative
(b)(4).
 
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Brand NamePHYSIOMESH
Type of DeviceMESH, SURGICAL
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
ken clark
route 22 west po box 151west p
o box 151
somerville, NJ 08876
9082183547
MDR Report Key5613473
MDR Text Key43838334
Report Number2210968-2016-08570
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
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,Followup
Report Date 04/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/07/2016
Was Device Evaluated by Manufacturer? No
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: 04/27/2016 Patient Sequence Number: 1
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