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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 2013-01-06 for * manufactured by *.

Event Text Entries

[20007868] A uterine sound was used as a device to feel the canal intramedullary and the tip of that, secondary to fatigue fracture, broke inside the canal and stayed inside the canal. It was deemed most safe in the bone rather than attempt to retrieve it.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2905912
• MDR Report Key: 2905912
• Date Received: 2013-01-06
• Date of Report: 2012-11-26
• Date of Event: 2012-07-19
• Report Date: 2012-11-26
• Date Reported to FDA: 2013-01-06
• Date Added to Maude: 2013-01-10
• 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
• 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: SOUND, UTERINE
• Product Code: HHM
• Date Received: 2013-01-06
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-01-06