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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN

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ETHICON INC. SUTURE UNKNOWN Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Inflammation (1932); Pain (1994); Burning Sensation (2146); Ambulation Difficulties (2544); No Code Available (3191)
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 a hernia repair procedure on (b)(6) 2013 and the suture was used. The day after the procedure, the patient experienced an intense burning pain in the groin. It was also reported that, within three months the patient could not walk due to the pain, and experienced high levels of inflammation in the blood. Three years later the patient is still experiencing pain and undergoing another surgery to remove the suture on (b)(6) 2017. Additional information has been requested.
 
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Brand NameSUTURE UNKNOWN
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
UNKNOWN
unknown
x
Manufacturer Contact
krystina laguna
route 22 westp o box 151
somerville, NJ 08876
9082183043
MDR Report Key6281563
MDR Text Key65899643
Report Number2210968-2017-30404
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2017
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 Received01/13/2017
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: 01/26/2017 Patient Sequence Number: 1
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