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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. VICRYL PLUS SUTURE 27"(70CM) 0 VIO; SUTURE, ABSORBABLE, SYNTHETIC
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ETHICON INC. VICRYL PLUS SUTURE 27"(70CM) 0 VIO; SUTURE, ABSORBABLE, SYNTHETIC Back to Search Results
Catalog Number VCP340H
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/31/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mp2295, 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 caesarean section on (b)(6) 2019 and suture was used.The suture was broken when pulling the suture during continuous suturing on the fascia.There were no adverse consequences to the patient.
 
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Brand Name
VICRYL PLUS SUTURE 27"(70CM) 0 VIO
Common Device Name
SUTURE, ABSORBABLE, SYNTHETIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key8730834
Report Number2210968-2019-83234
Device Sequence Number2022535
Product Code GAM
UDI-Device Identifier10705031052499
UDI-Public10705031052499
Combination Product (Y/N)N
Initial Reporter CountryJA
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) 06/03/2019
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 Date11/30/2023
Device Catalogue NumberVCP340H
Device Lot NumberMP2295
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/03/2019
Initial Report FDA Received Date06/25/2019
Patient Sequence Number1
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