OPTIVIEW LIP AND CHEEK RETRACTOR 716-0050

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-03-09 for OPTIVIEW LIP AND CHEEK RETRACTOR 716-0050 manufactured by Kerrhawe Sa.

Event Text Entries

[2628497] A doctor alleged that four (4) patients experienced an allergic reaction in the form of red blisters in the mouth and swelling of the lips after placement of the optiview lip and cheek retractor. This is the fourth of four (4) reports.
Patient Sequence No: 1, Text Type: D, B5


[9752930] The device and accompanying lip cushions were previously soaked in ventisept m plus disinfectant. The doctor suspected that the disinfectant could have been the cause of the allergic reaction as the blisters and swelling were concentrated primarily in the areas where the cushions had contact with the patient's mouth. The doctor prescribed kamillosan (an anti-inflammatory and antiseptic oropharyngeal) for the patient. To date, the patient is feeling better. The device involved in the alleged incident was not returned and no lot number was provided; therefore, no further investigation can be conducted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8020994-2012-00004
MDR Report Key2486101
Report Source05
Date Received2012-03-09
Date of Report2012-02-10
Date Mfgr Received2012-02-10
Date Added to Maude2012-03-12
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 FDA0
Event Location0
Manufacturer ContactMR. ORLANDO TADEO, JR.
Manufacturer Street1717 WEST COLLINS AVENUE
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal92867
Manufacturer Phone7145167419
Manufacturer G1KERRHAWE SA
Manufacturer StreetVIA STRECCE 4
Manufacturer CityBIOGGIO, CH-6934
Manufacturer CountrySZ
Manufacturer Postal CodeCH-6934
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOPTIVIEW LIP AND CHEEK RETRACTOR
Generic NameRETRACTOR, DENTAL
Product CodeEIG
Date Received2012-03-09
Catalog Number716-0050
OperatorDENTIST
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerKERRHAWE SA
Manufacturer AddressVIA STRECCE 4 BIOGGIO, CH-6934 SZ CH-6934


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-03-09

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