PREMIERPRO 8808

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-27 for PREMIERPRO 8808 manufactured by Sunmed Holdings, Llc..

MAUDE Entry Details

Report Number1314417-2019-00051
MDR Report Key9128912
Date Received2019-09-27
Date of Report2019-09-27
Date of Event2019-08-30
Date Added to Maude2019-09-27
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 ContactMS. CARRIE FORTUNA
Manufacturer Street2710 NORTHRIDGE DR. NW. SUITE A
Manufacturer CityGRAND RAPIDS MI 49544
Manufacturer CountryUS
Manufacturer Postal49544
Manufacturer Phone6162598400
Manufacturer G1SUNMED HOLDINGS LLC.
Manufacturer Street2710 NORTHRIDGE DR. NW SUITE A
Manufacturer CityGRAND RAPIDS MI 49544
Manufacturer CountryUS
Manufacturer Postal Code49544
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePREMIERPRO
Generic NamePRESSURE INFUSER BAG
Product CodeKZD
Date Received2019-09-27
Model Number8808
Lot Number190100054
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSUNMED HOLDINGS, LLC.
Manufacturer Address2710 NORTHRIDGE DR. NW. SUITE A GRAND RAPIDS MI 49544 US 49544


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-09-27

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