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U.S. Department of Health and Human Services

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

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ETHICON INC. ETHICON MESH UNKNOWN MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number ETHMESHUNK
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Cardiac Arrest (1762); Unspecified Infection (1930); Pain (1994); Renal Failure (2041); Hernia (2240); Peritonitis (2252)
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.
 
Event Description
It was reported that the patient underwent an unknown procedure in 2014 or 2015 to stop the hernias and to stop feces from passing in urine and mesh was implanted. The patient has experienced severe pain, infection, peritonitis, unspecified hernias and chronic renal failure. The patient is unable to take pain medication due to the renal failure. The patient is also unable to eat or drink for unspecified reasons and is on a drip due to dehydration. The patient has also suffered from a heart attack which the patient believes is due to the extreme pain. No additional information is available.
 
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Brand NameETHICON MESH UNKNOWN
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer (Section G)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key7068663
MDR Text Key93281269
Report Number2210968-2017-71486
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial
Report Date 11/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberETHMESHUNK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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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