OLIVE TIP FILIFORM 342104

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 1999-05-16 for OLIVE TIP FILIFORM 342104 manufactured by Rusch, Inc..

Event Text Entries

[16786854] It was reported that while being removed, the tip of the filiform became detached. Cystoscopy was performed and the tip was removed surgically.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2429473-1999-00040
MDR Report Key223699
Report Source06
Date Received1999-05-16
Date of Report1999-05-13
Date of Event1999-04-27
Date Mfgr Received1999-05-12
Date Added to Maude1999-05-20
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 NameOLIVE TIP FILIFORM
Generic NameFILIFORM
Product CodeFBW
Date Received1999-05-16
Model NumberNA
Catalog Number342104
Lot NumberE911607
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key216941
ManufacturerRUSCH, INC.
Manufacturer Address2450 MEADOWBROOK PKWY. DULUTH GA 30096 US
Baseline Brand NameOLIVE TIP FILIFORM
Baseline Generic NameFILIFORM
Baseline Model NoNA
Baseline Catalog No342104
Baseline IDNA
Baseline Device FamilyFILIFORM
Baseline Shelf Life Contained*
Baseline Shelf Life [Months]*
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentY
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1999-05-16

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