MAUDE Adverse Event Report: LAND AMERICA HEALTH & FITNESS BED, MANUAL; 880.5120

Model Number VC5310

Device Problem Product Quality Problem (1506)

Patient Problem Laceration(s) (1946)

Event Date 03/13/2014

Event Type  No Answer Provided  

Event Description

End user allegedly has no feeling in his right leg, was having spasms in bed rubbing his leg up against the bed rail which had a sharp edge, tbm stated the consumers right leg got all scratched up and they had to take him to the hospital, no additional information was provided.

• Brand Name: BED, MANUAL
• Type of Device: 880.5120
• Manufacturer (Section D): LAND AMERICA HEALTH & FITNESS; 25 north 2nd rd; xiamen fujian province 3610 22; CH 361022
• MDR Report Key: 3747048
• MDR Text Key: 4464686
• Report Number: 1531186-2014-01350
• Device Sequence Number: 1
• Product Code: FNJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/11/2014,03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VC5310
• 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: 04/11/2014
• Distributor Facility Aware Date: 03/14/2014
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 04/11/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other