HALYARD* STANDARD BACK TABLE COVER-NO-44 X 78-44 X 78-SOFT FOLD-HANDI-BIN 42216NS 104221600

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-07-15 for HALYARD* STANDARD BACK TABLE COVER-NO-44 X 78-44 X 78-SOFT FOLD-HANDI-BIN 42216NS 104221600 manufactured by O&m Halyard, Inc..

MAUDE Entry Details

Report Number3005997949-2019-00004
MDR Report Key8788959
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-07-15
Date of Report2019-07-30
Date of Event2019-04-23
Date Mfgr Received2019-07-30
Device Manufacturer Date2019-01-29
Date Added to Maude2019-07-15
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 ContactMR. SCOTT MCKENTLY
Manufacturer Street5405 WINDWARD PARKWAY
Manufacturer CityALPHARETTA 30004
Manufacturer CountryUS
Manufacturer Postal30004
Manufacturer Phone4704485926
Manufacturer G1AVENT SA DE R.L. DE C.V. (AVENT 3)
Manufacturer StreetAV. HIDALGO NO. 6 ESQ. BLVD. LUIS DONALDO COLOSIO
Manufacturer CityNOGALES, 84093
Manufacturer CountryMX
Manufacturer Postal Code84093
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHALYARD* STANDARD BACK TABLE COVER-NO-44 X 78-44 X 78-SOFT FOLD-HANDI-BIN
Generic NameEQUIPMENT COVERS
Product CodePUI
Date Received2019-07-15
Returned To Mfg2019-05-06
Model Number42216NS
Catalog Number104221600
Lot NumberAC9029081
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerO&M HALYARD, INC.
Manufacturer Address5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-15

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