SYNETURE VP-522-X

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 2019-03-14 for SYNETURE VP-522-X manufactured by Davis & Geck Caribe Ltd.

Event Text Entries

[138851904] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[138851905] According to the reporter, when suturing the vessel during an iliac femoral popliteal thromboendarterectomy procedure, the needle broke at swage. They used another suture pack to complete the case. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612501-2019-00510
MDR Report Key8422630
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-03-14
Date of Report2019-07-29
Date of Event2019-02-08
Date Mfgr Received2019-07-02
Device Manufacturer Date2018-07-20
Date Added to Maude2019-03-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLISA HERNANDEZ
Manufacturer Street195 MCDERMOTT RD
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925563
Manufacturer G1DAVIS & GECK CARIBE LTD
Manufacturer StreetZONA FRANCA DE SAN ISIDRO
Manufacturer CitySANTO DOMINGO 0101
Manufacturer CountryDO
Manufacturer Postal Code0101
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYNETURE
Product CodeOVN
Date Received2019-03-14
Returned To Mfg2019-03-08
Model NumberVP-522-X
Catalog NumberVP-522-X
Lot NumberD8G1844SX
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDAVIS & GECK CARIBE LTD
Manufacturer AddressZONA FRANCA DE SAN ISIDRO SANTO DOMINGO 0101 DO 0101


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-14

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