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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 18IN 4-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC
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ETHICON INC. MCRYL VIO 18IN 4-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC Back to Search Results
Model Number Y464G
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information was requested, and the following was obtained: please provide lot number.No further information is available.Please provide procedure date.No further information is available.No further information will be provided.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 a patient underwent an stoma closure procedure on an unknown date; and a suture was used.During the procedure, the suture broke while pulling the first stitch.There were no adverse patient consequences reported.Additional information was requested.
 
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Brand Name
MCRYL VIO 18IN 4-0 S/A P-3 PRM MP
Common Device Name
SUTURE, ABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key10531057
Report Number2210968-2020-06853
Device Sequence Number2720458
Product Code GAN
UDI-Device Identifier10705031059269
UDI-Public10705031059269
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K960653
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/04/2020
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 NumberY464G
Device Catalogue NumberY464G
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/04/2020
Initial Report FDA Received Date09/14/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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