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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, POLYMERIC

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ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHY1520V
Device Problem Appropriate Term/Code Not Available
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.

 
Event Description

It was reported by an attorney that the patient underwent a laparoscopic repair of an incisional hernia on (b)(6) 2012 and mesh was implanted. On (b)(6) 2016, the patient underwent surgery for recurrent ventral abdominal wall hernia secondary to disruption of the previous placed mesh and mesh infection. The procedure consisted of laparoscopic complete removal of her previously placed mesh and lysis of intestinal adhesions. The patient continues to experience pain. No additional information was provided.

 
Manufacturer Narrative

It was reported that following insertion the patient experienced nausea and chills.

 
Manufacturer Narrative

Additional information. In addition, a device history review has been inserted into the file.  this review indicates that there was no quality concerns associated with the manufacturing process.

 
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Brand NameETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL
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.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville , NJ 08876-0151
9082182792
MDR Report Key6642940
Report Number2210968-2017-60272
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 03/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/15/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/30/2013
Device Catalogue NumberPHY1520V
Device LOT NumberDJ8GMWA0
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 Received03/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2011
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: 06/15/2017 Patient Sequence Number: 1
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