SOLOGRIP III HANDPIECE HP-SG3

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,study report with the FDA on 2019-04-16 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc. ? Kennesaw.

Event Text Entries

[142185736] This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10


[142185737] According to initial reports, re-hospitalization due to atypical chest pain. Patient presented to outside hospital with acute chest pain; troponin normal, vitals unremarkable; lhc performed- 2 vessel disease, but no intervention; plan for medical management; patient discharged home (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1063481-2019-00019
MDR Report Key8520768
Report SourceCOMPANY REPRESENTATIVE,STUDY
Date Received2019-04-16
Date of Report2019-07-10
Date of Event2018-12-03
Date Facility Aware2019-04-08
Date Mfgr Received2019-04-08
Date Added to Maude2019-04-16
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 ContactROCHELLE MANEY
Manufacturer Street1655 ROBERTS BLVD
Manufacturer CityKENNESAW GA 30144
Manufacturer CountryUS
Manufacturer Postal30144
Manufacturer Phone7704193355
Manufacturer G1CRYOLIFE, INC.
Manufacturer Street1655 ROBERTS BLVD. NW
Manufacturer CityKENNESAW GA 30144
Manufacturer CountryUS
Manufacturer Postal Code30144
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSOLOGRIP III HANDPIECE
Generic NameSYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
Product CodeMNO
Date Received2019-04-16
Model NumberHP-SG3
Catalog NumberHP-SG3
Lot NumberUNKNOWN
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCRYOLIFE, INC. ? KENNESAW
Manufacturer Address1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-04-16

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