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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 3-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC
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ETHICON INC. VCL+ UD 27IN 3-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC Back to Search Results
Catalog Number VCP427H
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pa2714, and no non-conformances were identified.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 the patient underwent an unknown procedure on an unknown date and suture was used.The suture broke during the procedure.The procedure was completed successfully.There were no adverse patient consequences reported.
 
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Brand Name
VCL+ UD 27IN 3-0 S/A PS-2 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 Key9467371
Report Number2210968-2019-90889
Device Sequence Number4201873
Product Code GAM
UDI-Device Identifier10705031053151
UDI-Public10705031053151
Combination Product (Y/N)N
Initial Reporter CountrySN
PMA/510(K) Number
K032420
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) 11/22/2019
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 NumberVCP427H
Device Lot NumberPA2714
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/22/2019
Initial Report FDA Received Date12/13/2019
Patient Sequence Number1
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