54 SERIES 547T09-73

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-27 for 54 SERIES 547T09-73 manufactured by Champion Mfg. Inc..

Event Text Entries

[32762191] This was an unobserved fall. Patient found face down on the floor with recliner on top of him. Patient had a skin tear on his head. A ct scan was done. Medical treatment consisted of cleaning the tear and wrapping with gauze. Unknown if the patient was in the chair at the time that he fell or if he fell and tried to right himself after falling by pulling on the chair.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1834066-2015-00002
• MDR Report Key: 5260905
• Date Received: 2015-11-27
• Date of Report: 2015-11-24
• Date of Event: 2015-10-18
• Date Mfgr Received: 2015-10-22
• Device Manufacturer Date: 2007-01-01
• Date Added to Maude: 2015-12-02
• 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: 3
• Event Location: 3
• Manufacturer Contact: MATTHEW COPELAND
• Manufacturer Street: 2601 INDUSTRIAL PKWY.
• Manufacturer City: ELKHART IN 46516
• Manufacturer Country: US
• Manufacturer Postal: 46516
• Manufacturer Phone: 8009985018
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: 54 SERIES
• Generic Name: STANDARD MEDICAL RECLINER
• Product Code: FRJ
• Date Received: 2015-11-27
• Model Number: 547T09-73
• Catalog Number: 547T09-73
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CHAMPION MFG. INC.
• Manufacturer Address: 2601 INDUSTRIAL PKWY. ELKHART IN 46516 US 46516

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-11-27