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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO HERNIA SYSTEM MESH::10X12CM OVAL UNDERLAY MESH, SURGICAL, POLYMERIC

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ETHICON INC. ULTRAPRO HERNIA SYSTEM MESH::10X12CM OVAL UNDERLAY MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number XCUHSOV
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Pain (1994); Not Applicable (3189); No Code Available (3191)
Event Date 12/01/2011
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent. Attempts are being made to obtain the additional information. To date no response has been provided. If further details are received at the later date a supplemental medwatch will be sent. If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form.
 
Event Description
It was reported that the patient underwent an unknown surgical procedure on (b)(6) 2011 and the mesh was implanted. The patient experienced gastro problems accompanied with pain and at some point she passed out. The patient underwent an exploratory procedure to determine the issues and found that the device fell to the bottom. It was also reported that the device was removed on (b)(6) 2011 and replaced in the same procedure. She has also experienced bowel problems, problems having sex and decreased blood pressure. The patient is scheduled to have the mesh removal in (b)(6) 2019. Additional information has been requested.
 
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Brand NameULTRAPRO HERNIA SYSTEM MESH::10X12CM OVAL UNDERLAY
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
norderstedt
GM
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082183429
MDR Report Key8403445
MDR Text Key138220936
Report Number2210968-2019-79357
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K033337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2013
Device Catalogue NumberXCUHSOV
Device Lot NumberDB8CLGA0
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 Received12/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/04/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/08/2019 Patient Sequence Number: 1
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