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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. VCL MESH KNIT UD 12INX12IN MESH, SURGICAL, POLYMERIC

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ETHICON INC. VCL MESH KNIT UD 12INX12IN MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number VKML
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Diarrhea (1811); Fatigue (1849); Itching Sensation (1943); Nausea (1970); Pain (1994); Local Reaction (2035); Skin Irritation (2076); Obstruction/Occlusion (2422)
Event Date 03/20/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. 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. Additional information was requested and the following was obtained: please provide procedure date: (b)(6) 2020. What date did the symptoms occur on? (b)(6) 2020. Is there any surgical intervention planned? no. Any medical treatment provided? yes if yes, please provide medicine name, strength and dose. Allopurinol for joint pain 100mg/day. Were prescription steroids administered? yes twice. Were antibiotics prescribed? no. Current patient status? extreme joint pain, nausea, extreme fatigue, hot over the area and itchy.
 
Event Description
It was reported that a patient underwent an umbilical hernia procedure on (b)(6) 2020 and the mesh was implanted. It was reported that after the procedure the patient has experienced achy joints, extreme fatigue, tiredness, upset stomach, diarrhea, nausea, itching and hotness in stomach where mesh was inserted.
 
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Brand NameVCL MESH KNIT UD 12INX12IN
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.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo 00754
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10839930
MDR Text Key216394442
Report Number2210968-2020-09029
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K810428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberVKML
Device Catalogue NumberVKML
Device Lot NumberLL7034
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 Received10/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/16/2017
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: 11/13/2020 Patient Sequence Number: 1
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