VERSAONE BPT12STS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-24 for VERSAONE BPT12STS manufactured by Davis & Geck Caribe Ltd.

Event Text Entries

[185502675] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185502676] According to the reporter, prior to the procedure, the blue top of the obturator fell off. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612501-2020-00507
MDR Report Key9872448
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-24
Date of Report2020-03-24
Date Mfgr Received2020-03-05
Device Manufacturer Date2019-04-30
Date Added to Maude2020-03-24
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 ContactLISA HERNANDEZ
Manufacturer Street60 MIDDLETOWN AVE.
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 18750
Manufacturer CountryDO
Manufacturer Postal Code18750
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVERSAONE
Generic NameLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Product CodeGCJ
Date Received2020-03-24
Model NumberBPT12STS
Catalog NumberBPT12STS
Lot NumberJ9D2608DY
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDAVIS & GECK CARIBE LTD
Manufacturer AddressZONA FRANCA DE SAN ISIDRO SANTO DOMINGO 18750 DO 18750


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.