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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH 15X15Q MESH, SURGICAL, POLYMERIC

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ETHICON INC. PHYSIOMESH 15X15Q MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHY1515Q
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Erosion (1750); Diarrhea (1811); Fistula (1862); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Obstruction/Occlusion (2422); Weight Changes (2607); Decreased Appetite (4569)
Event Type  Injury  
Manufacturer Narrative

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 hernia repair surgery on (b)(6) 2015 and mesh was implanted. It was reported that the patient underwent removal surgery on (b)(6) 2018 during which the surgeon noted went along the medial aspect of the stomach where the old pouch, was nothing that the endoscopy had been with what appeared to be mesh material, found that this was again adhered and fistulized to the anterior abdominal wall where the previous mesh was placed. This was taken down and given that we had two areas of concern, one way where the mesh had eroded into the stomach and another way where the fistulous tract was in the fundus, the best plan of action given the gross obstruction of the stomach to perform a total gastrectomy. It was reported the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite, and extreme weight loss. No additional information was provided.

 
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Brand NamePHYSIOMESH 15X15Q
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-GMBH
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082182213
MDR Report Key11362282
MDR Text Key234323936
Report Number2210968-2021-01676
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK093932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/18/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/22/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2017
Device Catalogue NumberPHY1515Q
Device LOT NumberJB8DDKB1
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 Received02/24/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/13/2015
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: 02/22/2021 Patient Sequence Number: 1
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