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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO 10 X 15 CM, 3 / BOX MESH, SURGICAL, POLYMERIC

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ETHICON INC. ULTRAPRO 10 X 15 CM, 3 / BOX MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number UMN3
Device Problem Migration (4003)
Patient Problems Erosion (1750); Inflammation (1932); Pain (1994); Swelling (2091); Not Applicable (3189)
Event Date 12/21/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a 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?.

 
Event Description

It was reported by the patient that they underwent an unknown procedure on an unknown date and mesh was implanted. The patient experienced chronic pain since implantation. The patient reported severe swelling and inflammation after one week post-operative surgery. Eleven months after procedure, further surgery was required to trim out mesh. Additional information was requested.

 
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Brand NameULTRAPRO 10 X 15 CM, 3 / BOX
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
p.o. box 1409 d22841
norderstedt
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8324477
MDR Text Key135683766
Report Number2210968-2019-78728
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK033337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,FOREIGN,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/09/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUMN3
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 Received02/18/2019
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?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/09/2019 Patient Sequence Number: 1
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