Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 2-0 S/A FS-1; SUTURE, ABSORBABLE, SYNTHETIC
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON INC. VCL+ VIO 27IN 2-0 S/A FS-1; SUTURE, ABSORBABLE, SYNTHETIC Back to Search Results
Model Number VCP453H
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device, 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 that the cat underwent an ovariectomy procedure in (b)(6) 2019 and suture was used.Less than five days post op the animal presented with an inflammatory reaction and eventration.The overlock of the muscular wall with suture was ruptured.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VCL+ VIO 27IN 2-0 S/A FS-1
Common Device Name
SUTURE, ABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key9831748
Report Number2210968-2020-02063
Device Sequence Number14174656
Product Code GAM
UDI-Device Identifier10705031053366
UDI-Public10705031053366
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K032420
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date04/30/2022
Device Model NumberVCP453H
Device Catalogue NumberVCP453H
Device Lot NumberPEBCXGS0
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/19/2020
Initial Report FDA Received Date03/13/2020
Patient Sequence Number1
-
-