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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 2012-07-12 for * manufactured by *.

Event Text Entries

[19364816] While physician using instrument the locking mechanism on forceps broke. All pieces of the instrument were retrieved including the screw holding the locking mechanism. The instrument will be evaluated if repairable.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2679310
• MDR Report Key: 2679310
• Date Received: 2012-07-12
• Date of Report: 2012-05-02
• Report Date: 2012-05-02
• Date Reported to FDA: 2012-07-12
• Date Added to Maude: 2012-08-02
• 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
• 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: FORCEPS, DENTAL
• Product Code: EFL
• Date Received: 2012-07-12
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-07-12