RAY-BAN ORBS W 2311

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 1998-12-07 for RAY-BAN ORBS W 2311 manufactured by Bausch & Lomb, Inc..

Event Text Entries

[116159] Consumer alleges an injury requiring medical treatment, caused by his sunglasses when he was assaulted by another person.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1643383-1998-00004
MDR Report Key201193
Report Source04,05
Date Received1998-12-07
Date of Report1998-11-17
Date of Event1998-07-03
Date Mfgr Received1998-11-02
Date Added to Maude1998-12-14
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 Location3
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameRAY-BAN
Generic NameSUNGLASS
Product CodeHQY
Date Received1998-12-07
Returned To Mfg1998-08-17
Model NumberORBS
Catalog NumberW 2311
Lot NumberNA
ID NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityY
Device AgeNA
Device Eval'ed by Mfgr*
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key195428
ManufacturerBAUSCH & LOMB, INC.
Manufacturer Address5335 CASTROVILLE RD. SAN ANTONIO TX 78227 US
Baseline Brand NameRAY-BAN SUNGLASSES
Baseline Generic NameSUNGLASSES
Baseline Model NoORBS
Baseline Catalog NoW2451
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 1998-12-07

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