VERSACARE FRAME P3200K000004

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 2020-03-18 for VERSACARE FRAME P3200K000004 manufactured by Hill-rom Batesville.

MAUDE Entry Details

Report Number1824206-2020-00129
MDR Report Key9851242
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-18
Date of Report2020-03-11
Date of Event2020-03-11
Date Mfgr Received2020-03-11
Device Manufacturer Date2011-07-12
Date Added to Maude2020-03-18
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 ContactLORI DAULTON
Manufacturer Street1069 STATE ROUTE 46 EAST
Manufacturer CityBATESVILLE IN 47006
Manufacturer CountryUS
Manufacturer Postal47006
Manufacturer Phone8129312280
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVERSACARE FRAME
Generic NameBED, AC-POWERED ADJUSTABLE HOSPITAL
Product CodeFNL
Date Received2020-03-18
Model NumberP3200K000004
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHILL-ROM BATESVILLE
Manufacturer Address1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-18

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