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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-10-12 for * manufactured by *.

Event Text Entries

[517245] A patient who was discharged after undergoing a hysteroscopy and d & c in 2006 returned to the hospital 6 months later for the surgical removal for the next day, of a foreign object. The foregin object was identified as a curette tip, an instrument that would have been used during the initial procedure. The curette tip was removed intact and the patient left the o. R. In stable condition and was discharged to home the following day.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 770347
• MDR Report Key: 770347
• Date Received: 2006-10-12
• Date of Report: 2006-10-09
• Date of Event: 2006-04-04
• Date Facility Aware: 2006-10-08
• Report Date: 2006-10-09
• Date Reported to FDA: 2006-10-12
• Date Reported to Mfgr: 2006-10-12
• Date Added to Maude: 2006-10-19
• 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: 3
• 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: *
• Generic Name: CURETTE
• Product Code: FZS
• Date Received: 2006-10-12
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 758177
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-10-12