MAUDE Adverse Event Report: LAND AMERICA HEALTH & FITNESS SEMI ELECTRIC FOOT SPRING 9153638202; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 5310IVC

Device Problem Product Quality Problem (1506)

Patient Problem Discomfort (2330)

Event Type  Injury  

Event Description

The end user states he has a 5180 mattress on his bed.He states the mattress is bottoming out.He states the unit is less than a year old and his back hurts from the lack of support and has seen a doctor for the pain.He states he going to have an mri tomorrow for the pain as the doctor thinks it may be the sciatic nerve being pinched.

• Brand Name: SEMI ELECTRIC FOOT SPRING 9153638202
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): LAND AMERICA HEALTH & FITNESS; 25 north 2nd rd; xiamen fujian province 3610 22; CH 361022
• MDR Report Key: 4821676
• MDR Text Key: 5844628
• Report Number: 1531186-2015-01032
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/21/2015,05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5310IVC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2015
• Distributor Facility Aware Date: 05/18/2015
• Device Age: 19 MO
• Date Report to Manufacturer: 05/21/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention