IMAGE MANAGEMENT SYSTEM 660HD-E 72204668

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2019-08-23 for IMAGE MANAGEMENT SYSTEM 660HD-E 72204668 manufactured by Smith & Nephew, Inc..

MAUDE Entry Details

• Report Number: 1643264-2019-00563
• MDR Report Key: 8927890
• Report Source: FOREIGN,HEALTH PROFESSIONAL,O
• Date Received: 2019-08-23
• Date of Report: 2019-09-25
• Date of Event: 2019-07-27
• Date Mfgr Received: 2019-09-24
• Date Added to Maude: 2019-08-23
• 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: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: HOLLY TOPPING
• Manufacturer Street: 7000 WEST WILLIAM CANNON DRIVE
• Manufacturer City: AUSTIN TX 78735
• Manufacturer Country: US
• Manufacturer Postal: 78735
• Manufacturer Phone: 5123913905
• Manufacturer G1: SMITH & NEPHEW, INC.
• Manufacturer Street: 76 S. MERIDIAN AVE.
• Manufacturer City: OKLAHOMA CITY OK 731076512
• Manufacturer Country: US
• Manufacturer Postal Code: 731076512
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: IMAGE MANAGEMENT SYSTEM 660HD-E
• Generic Name: DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL
• Product Code: LMB
• Date Received: 2019-08-23
• Returned To Mfg: 2019-08-09
• Catalog Number: 72204668
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SMITH & NEPHEW, INC.
• Manufacturer Address: 76 S. MERIDIAN AVE. OKLAHOMA CITY OK 731076512 US 731076512

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-08-23