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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 Patient-Device Incompatibility (2682)
Patient Problems Distress (2329); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative
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 approximately a decade ago and mesh was implanted. The patient reported experiencing limited mobility and overall quality of life. The patient reported she is now crippled for life and emotionally distressed. No additional information has been provided.
 
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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)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7511175
MDR Text Key108162821
Report Number2210968-2018-72781
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 04/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/14/2018
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2018
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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