MAUDE Adverse Event Report: SPAN AMERICA MEDICAL SYSTEMS, INC. SPAN AMERICA; BEDSIDE SAFETY MAT

Model Number 94612

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 08/17/2020

Event Type  malfunction  

Event Description

A staff member slipped/fell on the bedside safety mat.There was no injury reported for this event.The grip strips, which help secure the mats to the floor with certain floor finishes, were not in use with this product.The mats are in place for resident fall safety.

• Brand Name: SPAN AMERICA
• Type of Device: BEDSIDE SAFETY MAT
• 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
• MDR Report Key: 10537443
• MDR Text Key: 208562417
• Report Number: 1041130-2020-00002
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 94612
• Device Catalogue Number: 94612
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• 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: Unknown
• Patient Sequence Number: 1