MAUDE Adverse Event Report: SPAN AMERICA MEDICAL SYSTEMS, INC. SPAN AMERICA; BEDSIDE FALL MATT

Model Number 37052

Device Problems Device Slipped (1584); Moisture or Humidity Problem (2986)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 12/16/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Mat was not defective, wet underneath.

Event Description

Cna (care giver) answered the call light and put the patient back in bed.As she walked away the bedside fall mat slipped and she fell to the floor bruising the left side of her leg.No immediate first aid or medical attention was given; however, she did later go to a doctor for x-rays which were negative.She was prescribed ibuprofen and baclofen.The incident report from both the employee and her supervisor state the reason for the slip was the bedside safety mat was wet underneath causing it to slide.

• Brand Name: SPAN AMERICA
• Type of Device: BEDSIDE FALL MATT
• Manufacturer (Section D): SPAN AMERICA MEDICAL SYSTEMS, INC.; 70 commerce center; greenville SC 29615
• Manufacturer (Section G): SPAN AMERICA MEDICAL SYSTEMS, INC.; 70 commerce center; greenville SC 29615
• Manufacturer Contact: william darby ; 70 commerce center; greenville, SC 29615 ; 8646786936
• MDR Report Key: 6257771
• MDR Text Key: 64976754
• Report Number: 1041130-2017-00001
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Device Unattended
• Device Model Number: 37052
• Device Catalogue Number: 37052
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other