WEE SIGHT 1017920

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-22 for WEE SIGHT 1017920 manufactured by Philips Medical Systems.

Event Text Entries

[124668979] Serial number not provided. A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10


[124668980] The customer stated that the wee sight that was stored in her purse and melted. There was no reported patient incident injury.
Patient Sequence No: 1, Text Type: D, B5


[130167264]
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1218950-2018-07691
MDR Report Key7991512
Date Received2018-10-22
Date of Report2018-09-25
Date Mfgr Received2018-09-25
Date Added to Maude2018-10-22
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 ContactMR. ROBERT CORNING
Manufacturer Street3000 MINUTEMAN ROAD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal01810
Manufacturer Phone9786871501
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameWEE SIGHT
Generic NameTRANSILLUMINTOR, BATTERY-POWERED
Product CodeHJN
Date Received2018-10-22
Returned To Mfg2018-10-08
Model Number1017920
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPHILIPS MEDICAL SYSTEMS
Manufacturer Address3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-22

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