29-5100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-22 for 29-5100 manufactured by Clorox Healthcare.

MAUDE Entry Details

Report Number8811316
MDR Report Key8811316
Date Received2019-07-22
Date of Report2019-01-24
Date of Event2019-01-03
Report Date2019-03-20
Date Reported to FDA2019-03-20
Date Reported to Mfgr2019-07-22
Date Added to Maude2019-07-22
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Generic NameUV DISINFECTION TOWER
Product CodeOSZ
Date Received2019-07-22
Model Number29-5100
Device Availability*
Device Age4 YR
Device Eval'ed by Mfgr*
Device Sequence No0
Device Event Key0
ManufacturerCLOROX HEALTHCARE
Manufacturer Address1221 BROADWAY OAKLAND CA 94612 US 94612

Device Sequence Number: 1

Generic NameUV DISINFECTION TOWER
Product CodeLKB
Date Received2019-07-22
Model Number29-5100
Device Availability*
Device Age4 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCLOROX HEALTHCARE
Manufacturer Address1221 BROADWAY OAKLAND CA 94612 US 94612


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-22

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