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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ULTRA COMFORT, SE 4 X 30 INTL; MATTRESS, FLOTATION THERAPY, NON-POWERED
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STRYKER MEDICAL-KALAMAZOO ULTRA COMFORT, SE 4 X 30 INTL; MATTRESS, FLOTATION THERAPY, NON-POWERED Back to Search Results
Catalog Number 1704034301
Device Problem Device Slipped (1584)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2024
Event Type  malfunction  
Event Description
This report summarizes 5 malfunction events, where it was reported the devices experienced inadequate retention force; support surface could slide off frame.There were 5 events with patient involvement; no adverse consequences were reported.
 
Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.5 devices were not evaluated and no cause was determined, as the customers did not make the devices accessible for testing.There was no remedial action taken.This device is not labeled for single use.
 
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Brand Name
ULTRA COMFORT, SE 4 X 30 INTL
Type of Device
MATTRESS, FLOTATION THERAPY, NON-POWERED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
melissa simon
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key19158497
MDR Text Key340936831
Report Number0001831750-2024-00485
Device Sequence Number1
Product Code IKY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported5
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number1704034301
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/01/2024
Initial Date FDA Received04/22/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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