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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. NUROLON NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE, SYNTHETIC
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ETHICON INC. NUROLON NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE, SYNTHETIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Anaphylactic Shock (1703)
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 by consumer that a patient underwent unknown fascial procedure on unknown date and suture was used.Approximately three hours post procedure, the patient experienced anaphylactic reaction.The patient face, tongue and throat were swollen.The surgeon opined that the suture may have contributed to the event.The current condition of the patient is unknown.No additional information is available.
 
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Brand Name
NUROLON NYLON SUTURE UNKNOWN PRODUCT
Type of Device
SUTURE, NONABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7728640
MDR Text Key115360981
Report Number2210968-2018-74698
Device Sequence Number1
Product Code GAR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K946173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 07/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received07/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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