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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM RECT; MESH, SURGICAL, POLYMERIC
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ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM RECT; MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number PHY1520R
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes Hernia (2240); No Code Available (3191)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event or Problem Description
It was reported by an attorney that the patient underwent a hernia repair surgery on (b)(6) 2015 and mesh was implanted.It was reported that the patient experienced an undisclosed adverse event.No additional information was provided.
 
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Brand Name
ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM RECT
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
MDR Report Key7114136
Report Number2210968-2017-71709
Device Sequence Number1234809
Product Code FTL
UDI-Device Identifier10705031132320
UDI-Public10705031132320
Combination Product (Y/N)N
PMA/510(K) Number
K093932
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue NumberPHY1520R
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 12/07/2017
Supplement Date Received by Manufacturer03/26/2018
Initial Report FDA Received Date12/13/2017
Supplement Report FDA Received Date04/16/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age42 YR
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