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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 27IN 2-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC
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ETHICON INC. MCRYL VIO 27IN 2-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC Back to Search Results
Model Number Y339H
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event or Problem Description
It was reported that a patient underwent an unknown surgery on an unknown date.During the procedure, the suture was detached from the needle immediately.It was not a control release needle.There were no adverse consequences to the patient.
 
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Brand Name
MCRYL VIO 27IN 2-0 S/A CT-1
Common Device Name
SUTURE, ABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key10973516
Report Number2210968-2020-09750
Device Sequence Number2538924
Product Code GAN
UDI-Device Identifier10705031058859
UDI-Public10705031058859
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K960653
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/12/2020
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 Model NumberY339H
Device Catalogue NumberY339H
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/12/2020
Initial Report FDA Received Date12/09/2020
Patient Sequence Number1
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