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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. ETHILON NYLON SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC
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ETHICON INC. ETHILON NYLON SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC Back to Search Results
Catalog Number 1603G
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Attempts have been made to retrieve the device.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.
 
Event Description
It was reported that the patient underwent an unknown procedure in 2017 and unknown suture was used.During the procedure, the needle fell off and when the surgeon attempted to tie a knot the suture would break.It is unknown how the procedure was completed.There were no patient consequences reported.No further information is available.
 
Manufacturer Narrative
Date send to the fda: 10/17/2017.
 
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Brand Name
ETHILON NYLON SUTURE
Type of Device
SUTURE, NONABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key6868499
MDR Text Key86447882
Report Number2210968-2017-70289
Device Sequence Number1
Product Code GAR
Combination Product (y/n)N
PMA/PMN Number
K946173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 08/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1603G
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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