RHOTON MICRE CURETTE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-11 for RHOTON MICRE CURETTE * manufactured by Carefusion Division Of V.mueller.

Event Text Entries

[21283354] During a cervical disk surgery, rhoton dissector (microcurette) broke off but the fragment was located by the neurosurgeon and removed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2028695
• MDR Report Key: 2028695
• Date Received: 2011-03-11
• Date of Report: 2011-03-11
• Date of Event: 2011-02-21
• Report Date: 2011-03-11
• Date Reported to FDA: 2011-03-11
• Date Added to Maude: 2011-03-24
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RHOTON MICRE CURETTE
• Generic Name: MICROCURETTE, ANGLED
• Product Code: GDI
• Date Received: 2011-03-11
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Age: 1 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CAREFUSION DIVISION OF V.MUELLER
• Manufacturer Address: 5 SUNNEN DR. SAINT LOUIS MO 63143 US 63143

Patients

Patient Number	Treatment	Outcome	Date
1	0		2011-03-11