VCL CT BRD UD 18IN 5-0 S/A P-1 PRIME V490H

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for VCL CT BRD UD 18IN 5-0 S/A P-1 PRIME V490H manufactured by Ethicon Inc..

Event Text Entries

[188520905] (b)(4). A manufacturing record evaluation was performed for the finished device pam853 batch number, and no non-conformances were identified. Attempts are made to obtain the device return for evaluation. 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. The device event of 2nd suture broke during same suturing procedure submitted via medwatch 2210968-2020-02396.
Patient Sequence No: 1, Text Type: N, H10


[188520906] It was reported that the patient underwent an unknown ent procedure on (b)(6) 2020 and the suture was used. The needle broke during suturing. No further information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2020-02397
MDR Report Key9884590
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-26
Date of Report2020-03-02
Date of Event2020-02-24
Date Mfgr Received2020-03-02
Device Manufacturer Date2019-01-09
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer StreetP.O. BOX 151, ROUTE 22 WEST
Manufacturer CitySOMERVILLE NJ 08876
Manufacturer CountryUS
Manufacturer Postal08876
Manufacturer Phone6107428552
Manufacturer G1ETHICON INC.-JUAREZ
Manufacturer StreetAVENIDA DE LAS TORRES 7125 COL SALVACAR
Manufacturer CityCIUDAD JUAREZ 32604
Manufacturer CountryMX
Manufacturer Postal Code32604
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVCL CT BRD UD 18IN 5-0 S/A P-1 PRIME
Generic NameSUTURE, ABSORBABLE, SYNTHETIC
Product CodeGAM
Date Received2020-03-26
Catalog NumberV490H
Lot NumberPAM853
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerETHICON INC.
Manufacturer AddressP.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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