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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 36"(90CM) 2-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC
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ETHICON INC. MONOCRYL SUTURE 36"(90CM) 2-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC Back to Search Results
Catalog Number Y732H
Medical Device Problem Code Detachment Of Device Component (1104)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/16/2018
Type of Reportable Event Malfunction
Additional 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 or Problem Description
It was reported that an animal underwent a surgical procedure on (b)(6) 2018 and suture was used.During the procedure, the needle popped off of the suture at the swage.Another like device was used to complete the procedure with no adverse patient consequences.No additional information was provided.
 
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Brand Name
MONOCRYL SUTURE 36"(90CM) 2-0 VIO
Common Device Name
SUTURE, ABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
MDR Report Key7241366
Report Number2210968-2018-70662
Device Sequence Number13742776
Product Code GAN
UDI-Device Identifier10705031059528
UDI-Public10705031059528
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K960653
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 01/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue NumberY732H
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/16/2018
Initial Report FDA Received Date02/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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