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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 36IN 0 S/A V-34; SUTURE, ABSORBABLE, SYNTHETIC
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ETHICON INC. VCL+ VIO 36IN 0 S/A V-34; SUTURE, ABSORBABLE, SYNTHETIC Back to Search Results
Catalog Number VCP518H
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/20/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mj7067, 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 cesarean section on an unknown date and suture was used.When sewing, the suture broke.Changed to a like device to complete surgery.There were no adverse patient consequences reported.
 
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Brand Name
VCL+ VIO 36IN 0 S/A V-34
Common Device Name
SUTURE, ABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key8964381
Report Number2210968-2019-86588
Device Sequence Number2520566
Product Code GAM
UDI-Device Identifier10705031054042
UDI-Public10705031054042
Combination Product (Y/N)N
Initial Reporter CountryCH
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) 08/09/2019
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 Date07/31/2023
Device Catalogue NumberVCP518H
Device Lot NumberMJ7067
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/09/2019
Initial Report FDA Received Date09/05/2019
Patient Sequence Number1
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