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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
Catalog Number PHY2025V
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Cramp(s) (2193); Hernia (2240); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event Description
It was reported by an attorney that the patient underwent a hernia repair procedure on (b)(6) 2011 and mesh was implanted. It was reported the patient experienced an undisclosed adverse event. No additional information was provided.
 
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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
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876-0151
6107428552
MDR Report Key9077803
MDR Text Key161742065
Report Number2210968-2019-87546
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 other
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2013
Device Catalogue NumberPHY2025V
Device Lot NumberDD8KWKA0
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 Received12/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2011
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: 09/17/2019 Patient Sequence Number: 1
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