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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ULTRA COMFRT, SE 4X30 DOMESTIC; MATTRESS, FLOTATION THERAPY, NON-POWERED
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STRYKER MEDICAL-KALAMAZOO ULTRA COMFRT, SE 4X30 DOMESTIC; MATTRESS, FLOTATION THERAPY, NON-POWERED Back to Search Results
Catalog Number 1704034300
Device Problem Device Slipped (1584)
Patient Problem Skin Tears (2516)
Event Date 11/07/2020
Event Type  malfunction  
Event Description
It was reported that the mattress slid off the stretcher litter; a patient was on the mattress at the time of the event.The patient was elderly and suffered a skin tear as a result of the event.Treatment information was not provided.
 
Manufacturer Narrative
The patient did not require nor receive any treatment for the skin tear.The facility did not make the device available for testing.
 
Event Description
It was reported that the mattress slid off the stretcher litter; a patient was on the mattress at the time of the event.The patient was elderly and suffered a skin tear as a result of the event.The patient did not require nor receive any treatment for the skin tear.
 
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Brand Name
ULTRA COMFRT, SE 4X30 DOMESTIC
Type of Device
MATTRESS, FLOTATION THERAPY, NON-POWERED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key10845675
MDR Text Key216668475
Report Number0001831750-2020-01206
Device Sequence Number1
Product Code IKY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/28/2021
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 No Information
Device Catalogue Number1704034300
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/11/2020
Initial Date FDA Received11/16/2020
Supplement Dates Manufacturer Received11/11/2020
Supplement Dates FDA Received01/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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