HARDY CURETTE 80-1346 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-03-14 for HARDY CURETTE 80-1346 * manufactured by Codman And Shurtleff, Inc..

Event Text Entries

[410446] A patient had an abnormality of the sphenoid sinus noted on a ct and an mri. The patient had a history of leimyosarcoma of the retroperitoneum. The mass was biopsied using a transseptal approach. During the procedure a 3 mm transphenoidal curette was used. The tip broke off of the curette and the operating surgeon was unable to locate it. A c-arm was brought in, but following the x-ray the tip was found on the drape. The x-ray showed nothing was inside the patient. The patient was determined to be uninjured.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 583643
• MDR Report Key: 583643
• Date Received: 2005-03-14
• Date of Report: 2005-03-14
• Date of Event: 2005-03-07
• Report Date: 2005-03-14
• Date Reported to FDA: 2005-03-14
• Date Added to Maude: 2005-03-23
• 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: HARDY CURETTE
• Generic Name: CURETTE
• Product Code: HTF
• Date Received: 2005-03-14
• Model Number: 80-1346
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 573470
• Manufacturer: CODMAN AND SHURTLEFF, INC.
• Manufacturer Address: 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US
• Baseline Brand Name: HARDY CURETTE
• Baseline Generic Name: CURETTE
• Baseline Model No: NA
• Baseline Catalog No: 80-1346
• Baseline ID: NA
• Baseline Device Family: HARDY CURETTE
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-03-14