HOYER PRESENCE WITH CRADLE AND SCALE HOY-PRESENCE4PTWSC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-03-09 for HOYER PRESENCE WITH CRADLE AND SCALE HOY-PRESENCE4PTWSC manufactured by Apex Health Care Mfg. Inc..

Event Text Entries

[5631153] Please reference importer report number (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3010605276-2015-00002
• MDR Report Key: 4609745
• Report Source: 08
• Date Received: 2015-03-09
• Date of Report: 2015-03-09
• Date of Event: 2013-05-05
• Date Mfgr Received: 2013-08-07
• Date Added to Maude: 2015-04-07
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: KEVIN WALLS
• Manufacturer Street: 33 GOLDEN EAGLE LANE
• Manufacturer City: LITTLETON CO 80127
• Manufacturer Country: US
• Manufacturer Postal: 80127
• Manufacturer G1: APEX HEALTH CARE MFG. INC.
• Manufacturer Street: NO. 6 INDUSTRIAL 2ND ROAD TOU CHIAO INDUSTRIAL PARK
• Manufacturer City: MIN HSIUNG SHIANG CHIAYI DISTRICT
• Manufacturer Country: TW
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HOYER PRESENCE WITH CRADLE AND SCALE
• Generic Name: PATIENT LIFTER WITH CRADLE AND SCALE
• Product Code: FNG
• Date Received: 2015-03-09
• Model Number: HOY-PRESENCE4PTWSC
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: APEX HEALTH CARE MFG. INC.
• Manufacturer Address: NO. 6 INDUSTRIAL 2ND ROAD TOU CHIAO INDUSTRIAL PARK MIN HSIUNG SHIANG CHIAYI DISTRICT TW

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2015-03-09