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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 2012-07-23 for * manufactured by Skytron.

Event Text Entries

[18418163] The patient was positioned for prostatectomy via davinci and the leg holder with metal bracket broke off and fell off the bed causing the patient's leg to fall.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2683592
• MDR Report Key: 2683592
• Date Received: 2012-07-23
• Date of Report: 2012-07-23
• Date of Event: 2012-07-09
• Report Date: 2012-07-23
• Date Reported to FDA: 2012-07-23
• Date Added to Maude: 2012-08-06
• 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: LEG HOLDER BED ATTACHMENT
• Product Code: BWN
• Date Received: 2012-07-23
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SKYTRON
• Manufacturer Address: 5085 CORPORATE EXCHANGE BLVD S GRAND RAPIDS MI 49512 US 49512

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-07-23