ADULT BULLARD LARYNGOSCOPE LARS-A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-03-08 for ADULT BULLARD LARYNGOSCOPE LARS-A manufactured by Acmii Norwalk.

MAUDE Entry Details

Report Number1519132-2004-00018
MDR Report Key534858
Report Source06
Date Received2004-03-08
Date of Report2004-03-08
Date of Event2004-01-01
Date Facility Aware2004-02-12
Report Date2004-03-08
Date Reported to FDA2004-02-01
Date Mfgr Received2004-02-12
Date Added to Maude2004-07-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactJOHN RING, JR.
Manufacturer Street136 TURNPIKE ROAD
Manufacturer CitySOUTHBOROUGH MA 017722104
Manufacturer CountryUS
Manufacturer Postal017722104
Manufacturer Phone5088042697
Manufacturer G1ACMI NORWALK
Manufacturer Street93 NORTH PLEASANT STREET
Manufacturer CityNORWALK OH 44857040
Manufacturer CountryUS
Manufacturer Postal Code44857 0409
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameADULT BULLARD LARYNGOSCOPE
Generic Name*
Product CodeEQN
Date Received2004-03-08
Model NumberLARS-A
Catalog NumberLARS-A
Lot NumberUNK
ID Number*
Device AvailabilityY
Device AgeUNKNOWN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key524130
ManufacturerACMII NORWALK
Manufacturer Address93 NORTH PLEASANT ST. NORWALK OH 448570409 US
Baseline Brand NameADULT BULLARD LARYNOSCOPE KITS
Baseline Generic NameLARYNGOSCOPE
Baseline Model NoLARS-A
Baseline Catalog NoLARS-A
Baseline IDNA
Baseline Device FamilyLARYNGOSCOPE
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK883819
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2004-03-08

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