URETHRAL CATHETER 334108

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-03-27 for URETHRAL CATHETER 334108 manufactured by Rusch Inc..

Event Text Entries

[121886] It was reported that the dr had problems sliding some catheters used. Majority of product in the same box worked fine. Only few can not be slid easily during use.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2429473-1998-00013
MDR Report Key161090
Report Source05,06
Date Received1998-03-27
Date of Report1998-03-27
Date Mfgr Received1998-03-27
Date Added to Maude1998-04-07
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameURETHRAL CATHETER
Generic NameCONE TIP URETHRAL CATHETER
Product CodeFGF
Date Received1998-03-27
Model NumberNA
Catalog Number334108
Lot Number803043
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key156866
ManufacturerRUSCH INC.
Manufacturer Address2450 MEADOWBROOK PKWY DULUTH GA 30136 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
101. Other 1998-03-27

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