DISCOVERY DISCOVERY-C N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-11-22 for DISCOVERY DISCOVERY-C N/A manufactured by Hologic, Inc..

Event Text Entries

[93234620] It was reported that they were having an intermittent issue where there were lines through the hip on scans, causing the patient to be rescanned. It was determined that the tx-encoder needed to be replaced. Once this was done the unit is working as intended.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1220984-2017-00208
• MDR Report Key: 7053050
• Report Source: USER FACILITY
• Date Received: 2017-11-22
• Date of Report: 2017-11-15
• Date of Event: 2017-09-20
• Date Mfgr Received: 2017-11-15
• Device Manufacturer Date: 2008-04-11
• Date Added to Maude: 2017-11-22
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RADIOLOGIC TECHNOLOGIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: DEBRA ROSENBERG
• Manufacturer Street: 36 & 37 APPLE RIDGE ROAD
• Manufacturer City: DANBURY CT 06810
• Manufacturer Country: US
• Manufacturer Postal: 06810
• Manufacturer Phone: 2032074512
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DISCOVERY
• Generic Name: DENSITOMETER, BONE
• Product Code: KGI
• Date Received: 2017-11-22
• Model Number: DISCOVERY-C
• Catalog Number: N/A
• Lot Number: N/A
• Operator: RADIOLOGIC TECHNOLOGIST
• Device Availability: N
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HOLOGIC, INC.
• Manufacturer Address: 36 & 37 APPLE RIDGE ROAD DANBURY CT 06810 US 06810

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2017-11-22