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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO ADVANCED MESH, SURGICAL, POLYMERIC

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ETHICON INC. ULTRAPRO ADVANCED MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UPA31515
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Diarrhea (1811); Nausea (1970); Chills (2191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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 removal surgery an recurrent hernia repair surgery on (b)(6) 2018 and the mesh was implanted during which the surgeon noted the previous mesh was protruding and was excited from the edges of the fascia. It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite, and extreme weight loss. It was reported that the patient previously underwent hernia repair surgery on (b)(6) 2008 and proceed was implanted. Other procedure is captured in a separate file. No additional information was provided.

 
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Brand NameULTRAPRO ADVANCED
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
9082183429
MDR Report Key10912566
MDR Text Key219366930
Report Number2210968-2020-09408
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK070224
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 11/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUPA31515
Device Catalogue NumberUPA31515
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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