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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
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Necrosis (1971); Pain (1994); Ambulation Difficulties (2544)
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 more additional information.
 
Event Description
It was reported that the patient underwent a bilateral inguinal hernia repair on (b)(6) 2015 and unknown mesh was implanted. Following the procedure, the patient developed complications such as severe pain that it made difficult to walk for the first three months and has been diagnosed with avascular necrosis. The surgeon opined that the mesh removal would make the situation worse. Additional information has been requested.
 
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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 NJ 08876 0151
Manufacturer (Section G)
UNKNOWN
unknown
x
Manufacturer Contact
darlene kyle
route 22 west po box 151
somerville, NJ 08876
9082182792
MDR Report Key6540115
MDR Text Key74284040
Report Number2210968-2017-31924
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 04/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received04/07/2017
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

Patient Treatment Data
Date Received: 05/03/2017 Patient Sequence Number: 1
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