BLUE NEOPRENE TEST LUNG 78176AP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2001-10-11 for BLUE NEOPRENE TEST LUNG 78176AP manufactured by Rusch Lurgan.

Event Text Entries

[231457] The customer reports that the test lung had a small hole in it.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010092-2001-00179
MDR Report Key356305
Report Source08
Date Received2001-10-11
Date of Report2001-10-11
Date Mfgr Received2001-10-08
Date Added to Maude2001-10-19
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
Manufacturer ContactDONNA MCLEOD, QUALITY ADMIN
Manufacturer Street2450 MEADOWBROOK PARKWAY
Manufacturer CityDULUTH GA 30096
Manufacturer CountryUS
Manufacturer Postal30096
Manufacturer Phone7706230816
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBLUE NEOPRENE TEST LUNG
Generic NameTEST LUNG
Product CodeBYW
Date Received2001-10-11
Model NumberNA
Catalog Number78176AP
Lot NumberUNK
ID NumberNA
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key345530
ManufacturerRUSCH LURGAN
Manufacturer AddressPOTADOWN ROAD * EI BT66 8RD
Baseline Brand NameBLUE NEOPRENE TEST LUNG
Baseline Generic NameBLUE NEOPRENE TEST LUNG
Baseline Model NoNA
Baseline Catalog No78176AP
Baseline IDNA
Baseline Device FamilyTEST LUNGS
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentY
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2001-10-11

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