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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 2009-12-07 for * manufactured by Bk Medical Systems, Inc..

Event Text Entries

[15629402] The tip of the introducer and handle came apart at ends where they are welded. No harm occurred to the patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1561280
• MDR Report Key: 1561280
• Date Received: 2009-12-07
• Date of Report: 2009-12-07
• Date of Event: 2009-11-24
• Report Date: 2009-12-07
• Date Reported to FDA: 2009-12-07
• Date Added to Maude: 2009-12-17
• 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: *
• Generic Name: INTRODUCER FOR RIGID PROCTOSCOPE
• Product Code: GCF
• Date Received: 2009-12-07
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BK MEDICAL SYSTEMS, INC.
• Manufacturer Address: 8 CENTENNIAL DRIVE PEABODY MA 01960 US 01960

Patients

Patient Number	Treatment	Outcome	Date
1	0		2009-12-07