CF INDICATOR 9800 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-08-27 for CF INDICATOR 9800 * manufactured by Medtronic Inc..

Event Text Entries

[218259] Sweat test ordered. Device in place 8 minutes. When removed, rt and parent noted 5 3-4mm areas on liner aspect of left thigh that was diagnosed as 2nd degree burns.
Patient Sequence No: 1, Text Type: D, B5


[233777] Add'l info rec'd from reporter 09/05/2001: product-device not applied according to mfr's guidelines. Corrective action in place. Mfr notified 09/05/01.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number349673
MDR Report Key349673
Date Received2001-08-27
Date of Report2001-08-27
Date of Event2001-08-24
Date Facility Aware2001-08-24
Report Date2001-08-27
Date Reported to FDA2001-08-27
Date Reported to Mfgr2001-08-27
Date Added to Maude2001-09-05
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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 Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCF INDICATOR
Generic NameCONTROLLER KIT
Product CodeKTB
Date Received2001-08-27
Model Number9800
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age9 YR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key338977
ManufacturerMEDTRONIC INC.
Manufacturer Address7000 CENTRAL AVE NE MINNEAPOLIS MN 55432 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2001-08-27

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