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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 18IN 6-0 S/A P-1 PRM; SUTURE, ABSORBABLE, SYNTHETIC
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ETHICON INC. MCRYL UD 18IN 6-0 S/A P-1 PRM; SUTURE, ABSORBABLE, SYNTHETIC Back to Search Results
Catalog Number Y489G
Medical Device Problem Code Material Separation (1562)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/26/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 a later date a supplemental medwatch will be sent.
 
Event or Problem Description
It was reported that an animal underwent a procedure on (b)(6) 2018 and suture was used.During the procedure, the needle came off the suture.There were no adverse consequences reported.No additional information was provided.
 
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Brand Name
MCRYL UD 18IN 6-0 S/A P-1 PRM
Common Device Name
SUTURE, ABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key7710275
Report Number2210968-2018-74541
Device Sequence Number19478009
Product Code GAN
UDI-Device Identifier10705031059276
UDI-Public10705031059276
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K964072
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,health profession
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/27/2018
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 Expiration Date07/31/2022
Device Catalogue NumberY489G
Device Lot NumberLJZ181
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/27/2018
Initial Report FDA Received Date07/23/2018
Patient Sequence Number1
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