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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO PLUG (LARGE); MESH, SURGICAL, POLYMERIC
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ETHICON INC. ULTRAPRO PLUG (LARGE); MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number UPPL2
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes Hernia (2240); Not Applicable (3189)
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
It was reported by an attorney that the patient underwent a hernia repair surgery on (b)(6) 2010 and mesh was implanted.It was reported that she experienced undisclosed injuries.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 following insertion the patient experienced recurrent ventral hernia.No additional information was provided.
 
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Brand Name
ULTRAPRO PLUG (LARGE)
Common Device Name
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key7474021
Report Number2210968-2018-72156
Device Sequence Number18864032
Product Code FTL
UDI-Device Identifier10705031132429
UDI-Public10705031132429
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K070224
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/11/2018
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 NumberUPPL2
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/02/2018
Initial Report FDA Received Date04/30/2018
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 Age57 YR
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