RUSCH 334108

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 2002-02-13 for RUSCH 334108 manufactured by Rusch, Inc..

Event Text Entries

[243643] The customer reports that they cannot aerate through the cone tip ureteral.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2429473-2002-00031
MDR Report Key377984
Report Source06
Date Received2002-02-13
Date of Report2002-02-12
Date Mfgr Received2002-02-05
Date Added to Maude2002-02-25
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 NameRUSCH
Generic NameCONE TIP URETERAL 8 FR
Product CodeFGF
Date Received2002-02-13
Model NumberNA
Catalog Number334108
Lot Number110823
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key367031
ManufacturerRUSCH, INC.
Manufacturer Address2450 MEADOWBROOK PKWY. DULUTH GA 30096 US
Baseline Brand NameCONE TIP URETERAL 8FR
Baseline Generic NameURETERAL CATHETER
Baseline Model NoNA
Baseline Catalog No334108
Baseline IDNA
Baseline Device FamilyURETERAL CATHETERS
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentY
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2002-02-13

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