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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ULTRA COMFORT, SE 4 X 26 W/FB; MATTRESS, FLOTATION THERAPY, NON-POWERED
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STRYKER MEDICAL-KALAMAZOO ULTRA COMFORT, SE 4 X 26 W/FB; MATTRESS, FLOTATION THERAPY, NON-POWERED Back to Search Results
Catalog Number 1704034601
Device Problem Device Slipped (1584)
Patient Problem Injury (2348)
Event Date 02/05/2019
Event Type  Injury  
Event Description
It was reported that a paramedic was injured while forcing on his back during patient transfers.The customer indicates that the mattress slips insufficiently and makes the patient transfer difficult.As a consequence, the paramedic went on sick leave for 15 days.
 
Manufacturer Narrative
It was reported that the injury had occurred due to the mattress sliding off of the litter.It was stated that while attempting to transfer the patient the mattress had slid off the litter with the patient.The caregiver tried to catch the mattress and allegedly hurt his back.It was confirmed that the patient did not receive an injury as a result of this alleged event, but that the caregiver went on sick leave for 15 days due to his back injury.The customer did not record the serial number of the device at the time of the alleged event.Device could not be identified.
 
Event Description
It was reported that a paramedic was injured while forcing on his back during patient transfers.The customer indicates that the mattress slips insufficiently and makes the patient transfer difficult.As a consequence, the paramedic went on sick leave for 15 days.
 
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Brand Name
ULTRA COMFORT, SE 4 X 26 W/FB
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
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key8344456
MDR Text Key136302341
Report Number0001831750-2019-00269
Device Sequence Number1
Product Code IKY
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 04/01/2019
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 Catalogue Number1704034601
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/05/2019
Initial Date FDA Received02/15/2019
Supplement Dates Manufacturer Received02/05/2019
Supplement Dates FDA Received04/01/2019
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
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