OMNIQUEST NOT LEGIBLE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-08-18 for OMNIQUEST NOT LEGIBLE * manufactured by Metrologic Instruments, Inc..

Event Text Entries

[1478226] Scheduled at check stations regularly during (b)(6) 2008. New laser scanners added to narcotic station, which faced the 4 check stations. Pharmacist refused to tilt down her tiltable, multifaceted 4 x 4 window barcode scanner and placed it at eye level directed toward the northern "inward" swinging egress door and the check stations. She directed her the reader of her pill counter toward to southern inward swinging egress door (excuse was cord too short). During periods required to check medications at check station, i would get migraine-like headache immediately following exposure to flickering beams. Repeated events during that month. No action taken to correct by (b)(6). After several episodes of exposure, noticed upper peripheral double-vision. (b)(6), started colored dazzling left side of left eye. Emergency visit to ophthalmologist. Lab for graves double-vision (recent radioisotope tx for elev t3 of thyroid). It appears that the weak muscles of the eyes reacted violently to the large window of sharp flickering laser lights of the barcode scanner. Possibly from power surge; probably loss of ability to overcome blink reflex. The flash never explained, but likely beginning of the neurological damage later resulting blepharospasms and meige's. Later symptoms not as obvious as the double-vision, which continued to worsen as the muscles behind the eye became more swollen. The only other symptom experienced was the inability to hold a forward gaze. Cont exposure. None of these lasers were properly labeled with readily visible fda inspection stickers or warning labels. Our lso dismissed the matter. Management refused to follow osha guidelines and control the direct eye contact from the beams. The asst dir of pharm did replace the flickering scanner with a handheld unit, but did not remove the original scanner and pharmacist repeated reinstalled the unit. Over time, her single source laser also started to burn and irritate my eyes. Still no control by management. (b)(6) (over 6 months later), provided extra pair of dark blue laser glasses, labeled kryton. No attempt to provide properly fit glasses for condition. As double-vision diminishes, neurological spasms continue to worsen. Developed neuro spasms in eyelids, facial muscles, neck and shoulders with intermittent... Dose or amount: exposure over extended period, frequency: continuous/repeated, route: direct eye contact. Dates of use: (b)(6)2008 - (b)(6)2009. Event abated after use: no. Event reappeared after reintroduction: yes. Multifaceted barcode scanner was made in (b)(4) and manufactured in (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5017416
MDR Report Key1837587
Date Received2010-08-18
Date of Report2010-08-02
Date of Event2008-06-25
Date Added to Maude2010-09-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPHARMACIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameOMNIQUEST
Generic NameCLASS II OR IIM BARCODE SCANNERS (ONE FOR PILL COUNTING AND
Product CodeNEP
Date Received2010-08-18
Model NumberNOT LEGIBLE
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerMETROLOGIC INSTRUMENTS, INC.
Manufacturer Address* BLACKWOOD NJ * US *

Device Sequence Number: 2

Brand NameOMNIQUEST
Generic NameCLASS II OR IIM BARCODE SCANNERS (ONE FOR PILL COUNTING AND ONE FOR SCANNING PRE
Product CodeLRH
Date Received2010-08-18
Model NumberS6520 RS-232
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No2
Device Event Key0
ManufacturerMETROLOGIC INSTRUMENTS, INC.
Manufacturer AddressBLACKWOOD NJ US


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2010-08-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.