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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Diarrhea (1811); Hemorrhage/Bleeding (1888); Inflammation (1932); Nausea (1970); Pain (1994); Seroma (2069); Chills (2191)
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. (b)(4) submitted for adverse event which occurred on (b)(6) /2016. (b)(4) submitted for adverse event which occurred on (b)(6) 2020.
 
Event Description
It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2012 and mesh was implanted. It was reported that the patient underwent hernia repair surgery on (b)(6) 2016 and mesh was implanted. It was reported the patient underwent removal surgery on (b)(6) 2020. It was reported that the patient experienced pain, nausea, diarrhea, chills, inflammation, bleeding, dense adhesions, adhesions to the bowel and small intestine, and seroma. Other procedure is captured under separate file. No additional information was provided.
 
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Brand NameETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-GMBH
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12566626
MDR Text Key274435360
Report Number2210968-2021-09114
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 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2013
Device Catalogue NumberPHY1520V
Device Lot NumberDB8BGLA0
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 Received10/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2011
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: 10/03/2021 Patient Sequence Number: 1
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