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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPAN AMERICA MEDICAL SYSTEMS, INC. RISK MANAGER; BEDSIDE FALL MAT
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SPAN AMERICA MEDICAL SYSTEMS, INC. RISK MANAGER; BEDSIDE FALL MAT Back to Search Results
Model Number 9611836
Device Problem Device Slipped (1584)
Patient Problems Fall (1848); Bone Fracture(s) (1870)
Event Date 06/07/2018
Event Type  Injury  
Manufacturer Narrative
The risk manager has optional grip strips for use on certain floor surfaces to help prevent movement of the mats.The mat was not used with the grip strips.
 
Event Description
Staff member stepped on the risk manager, the mat slipped from underneath her, she fell and landed on both wrists.She sustained bilateral wrist fracture, fracture on each wrist with casts on both wrists.She went to the er, received treatment including casts and is being followed up by the fracture clinic.
 
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Brand Name
RISK MANAGER
Type of Device
BEDSIDE FALL 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
8002888877
MDR Report Key7728734
MDR Text Key115350667
Report Number1041130-2018-00002
Device Sequence Number1
Product Code IKX
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 07/27/2018
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? No
Device Operator No Information
Device Model Number9611836
Device Catalogue Number9611836
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 07/17/2018
Initial Date FDA Received07/27/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
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