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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL MESH, SURGICAL

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ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL MESH, SURGICAL Back to Search Results
Catalog Number PHY1520V
Device Problems Hole In Material (1293); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Hernia (2240); No Code Available (3191)
Event Date 03/01/2016
Event Type  Injury  
Manufacturer Narrative
Date sent to fda: 3/14/2019.
 
Manufacturer Narrative
Date sent to fda: 06/05/2019.
 
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.
 
Event Description
It was reported that the patient underwent a laparoscopic ventral hernia repair procedure near the umbilicus on (b)(6) 2015 and the mesh was implanted. On (b)(6) 2016, the patient developed pain at the hernia site, the pain had worsened and the patient went to the emergency department where testing was done and was diagnosed with a recurrent hernia. The patient underwent a laparoscopic reoperation on (b)(6) 2016 and the mesh was found to be torn. A double-walled mesh was used to repair the hernia. It was also reported by the patient that he has recovered from the procedure and is now doing much better. Additional information has been requested.
 
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Brand NameETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL
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
kenneth clark
route 22 westp o box 151
somerville, NJ 08876
9082183547
MDR Report Key5869805
MDR Text Key193156818
Report Number2210968-2016-11260
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 consumer,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPHY1520V
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 Received05/21/2019
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: 08/11/2016 Patient Sequence Number: 1
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