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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. VICRYL RAPIDE SUTURE 27"(70CM) 3-0 UND; SUTURE, ABSORBABLE, SYNTHETIC
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ETHICON INC. VICRYL RAPIDE SUTURE 27"(70CM) 3-0 UND; SUTURE, ABSORBABLE, SYNTHETIC Back to Search Results
Model Number VR416
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/14/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 a patient underwent an ob-gyn procedure on (b)(6) 2020; and a suture was used.During the procedure, the suture broke easily during continuous suturing.There were no adverse patient consequences reported.No additional information was provided.
 
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Brand Name
VICRYL RAPIDE SUTURE 27"(70CM) 3-0 UND
Common Device Name
SUTURE, ABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key10465779
Report Number2210968-2020-06489
Device Sequence Number14124945
Product Code GAM
UDI-Device Identifier10705031134645
UDI-Public10705031134645
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K033746
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) 08/19/2020
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 Model NumberVR416
Device Catalogue NumberVR416
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/19/2020
Initial Report FDA Received Date08/28/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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