READY HEAT INFANT WARMING MATTRESS PART# S2RHIM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-23 for READY HEAT INFANT WARMING MATTRESS PART# S2RHIM manufactured by Tech Trade Llc.

MAUDE Entry Details

Report NumberMW5089968
MDR Report Key9106084
Date Received2019-09-23
Date of Report2019-09-19
Date of Event2019-09-12
Date Added to Maude2019-09-23
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameREADY HEAT INFANT WARMING MATTRESS
Generic NameBEDDING, DISPOSABLE, MEDICAL
Product CodeKME
Date Received2019-09-23
Model NumberPART# S2RHIM
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerTECH TRADE LLC
Manufacturer AddressJERSEY CITY NJ 07302 US 07302


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-09-23

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