HOUSE CURETTES, 7 1/8", DOUBLE-ENDED, 2MMX2.5MM A * 385-400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-05-03 for HOUSE CURETTES, 7 1/8", DOUBLE-ENDED, 2MMX2.5MM A * 385-400 manufactured by Hebumedical Gmbh.

Event Text Entries

[470895] Customer reported during a tympanoplasty procedur, the cup of hte curette broke off. The surgeon doesn't know if the tip is in the pt's ear or flew off onto the drape or floor. The surgeon has scheduled an x-ray to cofirm. The surgeon reported that if the instrument piece is in the pt's ear. It should not cause any problems, however, the surgeon has questioned whether it is magnetic in the event pt requires an mri at a later time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2430952-2006-00017
MDR Report Key710099
Date Received2006-05-03
Date of Report2006-05-01
Date Facility Aware2006-03-31
Report Date2006-05-01
Date Added to Maude2006-05-11
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHOUSE CURETTES, 7 1/8", DOUBLE-ENDED, 2MMX2.5MM A
Generic Name*
Product CodeFZS
Date Received2006-05-03
Model Number*
Catalog Number385-400
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key699147
ManufacturerHEBUMEDICAL GMBH
Manufacturer Address* TUTTLINGEN *


Patients

Patient NumberTreatmentOutcomeDate
10 2006-05-03

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