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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 36"(90CM) 3-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC
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ETHICON INC. MONOCRYL SUTURE 36"(90CM) 3-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC Back to Search Results
Catalog Number Y527H
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/06/2018
Event Type  malfunction  
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 a patient underwent an unknown procedure on (b)(6) 2018 and suture was used.During the procedure, the suture detached from the needle.It was not a control release needle.There were no adverse consequences to the patient.No additional information has been provided.
 
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Brand Name
MONOCRYL SUTURE 36"(90CM) 3-0 VIO
Type of Device
SUTURE, ABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7657460
MDR Text Key113006045
Report Number2210968-2018-74015
Device Sequence Number1
Product Code GAN
UDI-Device Identifier10705031059450
UDI-Public10705031059450
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K960653
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 06/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberY527H
Was Device Available for Evaluation? No
Date Manufacturer Received06/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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