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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 36"(90CM) 0 VIO; SUTURE, ABSORBABLE, SYNTHETIC
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ETHICON INC. MONOCRYL SUTURE 36"(90CM) 0 VIO; SUTURE, ABSORBABLE, SYNTHETIC Back to Search Results
Catalog Number Y987H
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/03/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pam110 batch number, and no non-conformances were identified.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.
 
Event or Problem Description
It was reported by vet that a dog underwent an animal surgery on (b)(6) 2019 and the suture was used to close the incision.Post-operatively, the suture was found to be broken down in incision.
 
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Brand Name
MONOCRYL SUTURE 36"(90CM) 0 VIO
Common Device Name
SUTURE, ABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key9325574
Report Number2210968-2019-89941
Device Sequence Number1927044
Product Code GAN
UDI-Device Identifier10705031060005
UDI-Public10705031060005
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K960653
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/25/2019
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 Date12/31/2023
Device Catalogue NumberY987H
Device Lot NumberPAM110
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/25/2019
Initial Report FDA Received Date11/14/2019
Patient Sequence Number1
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