BONE DENSITOMETER QDR1000 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-09-26 for BONE DENSITOMETER QDR1000 * manufactured by Hologic, Inc..

Event Text Entries

[16400151] Patient sat on bone density table. Rivets on plexiglass frame broke, plexiglass fell into table leaving a hole under patient as she lay supine on table.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 766975
• MDR Report Key: 766975
• Date Received: 2006-09-26
• Date of Report: 2006-09-25
• Date of Event: 2006-09-20
• Report Date: 2006-09-25
• Date Reported to FDA: 2006-09-26
• Date Added to Maude: 2006-10-06
• 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: 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: BONE DENSITOMETER
• Generic Name: TABLE, PROCEDURE, BONE DENSITY
• Product Code: KGI
• Date Received: 2006-09-26
• Model Number: QDR1000
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Age: 16 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 754876
• Manufacturer: HOLOGIC, INC.
• Manufacturer Address: 35 CROSBY DRIVE BEDFORD MA 01730 US
• Baseline Brand Name: BONE DENSITOMETER
• Baseline Generic Name: BONE DENSITOMETER, TABLE
• Baseline Model No: QDR 1000
• Baseline Catalog No: *
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-09-26