DERMAFLOAT LAL SYSTEM DFLAL-3680-M

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-13 for DERMAFLOAT LAL SYSTEM DFLAL-3680-M manufactured by Joerns Healthcare.

MAUDE Entry Details

Report Number3009402404-2020-00004
MDR Report Key9581253
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-01-13
Date of Report2020-01-13
Date of Event2019-12-08
Date Mfgr Received2019-12-16
Date Added to Maude2020-01-13
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 ContactFELICIA BANKS
Manufacturer Street2100 DESIGN ROAD
Manufacturer CityARLINGTON TX 76014
Manufacturer CountryUS
Manufacturer Postal76014
Manufacturer Phone8008260270
Manufacturer G1JOERNS HEALTHCARE
Manufacturer StreetAVENIDA PEDRO HINOJOSA NO.26 CIUDAD INDUSTRIAL
Manufacturer CityMATAMOROS, TAMAULIPAS 87499
Manufacturer CountryMX
Manufacturer Postal Code87499
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDERMAFLOAT LAL SYSTEM
Generic NamePATIENT AIR MATTRESS
Product CodeFNM
Date Received2020-01-13
Model NumberDFLAL-3680-M
Catalog NumberDFLAL-3680-M
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerJOERNS HEALTHCARE
Manufacturer AddressAVENIDA PEDRO HINOJOSA NO.26 CIUDAD INDUSTRIAL MATAMOROS, TAMAULIPAS 87499 MX 87499


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-13

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