OPTIVIEW SMALL KIT 5502

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-16 for OPTIVIEW SMALL KIT 5502 manufactured by Kerr Hawe Sa.

Event Text Entries

[62682182] The symptoms were treated with bentelan. To date, the patient is doing fine. The product was not returned and no lot number was provided; therefore, no evaluation was conducted.
Patient Sequence No: 1, Text Type: N, H10


[62682183] A dentist indicated two (2) patients experienced an allergic reaction resulting in swollen lips, pain, and ulcers approximately two hours after treatment involving optiview small kit. This is the second of two reports.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8021023-2016-00003
MDR Report Key6183583
Date Received2016-12-16
Date of Report2016-11-16
Date Mfgr Received2016-11-16
Date Added to Maude2016-12-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. MARK DZENDZEL
Manufacturer Street1717 W COLLINS AVE
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal92867
Manufacturer Phone7145167802
Manufacturer G1KERR HAWE S.A
Manufacturer StreetVIA STRECCE 4
Manufacturer City6934 BIOGGIO,
Manufacturer CountrySZ
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameOPTIVIEW SMALL KIT
Generic NameLIP AND CHEEK RETRACTOR
Product CodeEIG
Date Received2016-12-16
Catalog Number5502
OperatorDENTIST
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerKERR HAWE SA
Manufacturer AddressVIA STRECCE 4 6934 BIOGGIO, SWITZERLAND SZ


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2016-12-16

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