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 * report with the FDA on 2012-03-08 for OPTIVIEW LIP AND CHEEK RETRACTOR 716-0050 manufactured by Kerrhawe Sa.

Event Text Entries

[2629491] 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 first of four (4) reports.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2016150-2012-00008
MDR Report Key2484530
Report Source*
Date Received2012-03-08
Date of Report2012-02-10
Date Facility Aware2012-02-10
Report Date2012-03-08
Date Reported to FDA2012-03-08
Date Reported to Mfgr2012-03-08
Date Added to Maude2012-03-08
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
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
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOPTIVIEW LIP AND CHEEK RETRACTOR
Generic NameRETRACTOR, DENTAL
Product CodeEIG
Date Received2012-03-08
Catalog Number716-0050
OperatorDENTIST
Device AvailabilityN
Device Eval'ed by Mfgr*
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 2012-03-08

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