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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPAN-AMERICA MEDICAL SYSTEMS, INC. ISCH DISH ISCH DISH WHEEL CHAIR CUSHION

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SPAN-AMERICA MEDICAL SYSTEMS, INC. ISCH DISH ISCH DISH WHEEL CHAIR CUSHION Back to Search Results
Catalog Number 224C
Event Date 04/19/2010
Event Type  Injury  
Manufacturer Narrative

Foam has creased from rolling up on sides in wheelchair. The cushion was approx 1 yr old. Each cushion is shipped with a base to be used if the wheelchair surface is not flat / tight. The user was not using the base and from the foam creases it appears that the wheelchair base was not flat. Use and care instructions are provided with the product for users to check skin for any signs of redness or breakdown. We have not had any other occurrences of this nature.

 
Event Description

Customer reported that (b) (4) cushion bottomed out, resulting in pressure sore.

 
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Brand NameISCH DISH
Type of DeviceISCH DISH WHEEL CHAIR CUSHION
Manufacturer (Section D)
SPAN-AMERICA MEDICAL SYSTEMS, INC.
Manufacturer Contact
derrill darby
70 commerce center
greenville , SC 29615
8646786936
MDR Report Key1691847
Report Number1041130-2010-00004
Device Sequence Number1
Product CodeIMP
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Remedial Action Replace
Type of Report Initial
Report Date 05/14/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/14/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number224C
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer04/23/2010
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/19/2010
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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