SUN CLOUD DOCINI 42660570

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 1997-12-04 for SUN CLOUD DOCINI 42660570 manufactured by Bausch & Lomb, Inc..

Event Text Entries

[77745] Consumer alleges an inquiry requiring medical treatment, caused by her sunglasses when she fell on her face while bicycling.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1643383-1997-00010
MDR Report Key136812
Report Source04,05
Date Received1997-12-04
Date of Report1997-11-28
Date of Event1997-08-31
Date Mfgr Received1997-09-29
Date Added to Maude1997-12-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameSUN CLOUD
Generic NameSUNGLASS
Product CodeHQY
Date Received1997-12-04
Returned To Mfg1997-09-29
Model NumberDOCINI
Catalog Number42660570
Lot NumberNA
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityY
Device AgeNA
Device Eval'ed by Mfgr*
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key133647
ManufacturerBAUSCH & LOMB, INC.
Manufacturer Address5335 CASTROVILLE RD. SAN ANTONIO TX 78227 US
Baseline Brand NameSUNCLOUD
Baseline Generic NameSUNGLASSES
Baseline Model NoDOCINI
Baseline Catalog No42660570
Baseline IDNA
Baseline Device FamilyNA
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentY
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1997-12-04

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