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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO IMPRESSION MED SURG SURFACE; MATTRESS, FLOTATION THERAPY, NON-POWERED
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STRYKER MEDICAL-KALAMAZOO IMPRESSION MED SURG SURFACE; MATTRESS, FLOTATION THERAPY, NON-POWERED Back to Search Results
Catalog Number 2981000997
Device Problem Moisture Damage (1405)
Patient Problem Tissue Breakdown (2681)
Event Date 02/28/2014
Event Type  Injury  
Event Description
It was reported by the user facility that the patient's skin may have broke down while on the mattress.It was also reported there may have been fluid ingress.There was patient involvement; however, no clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
It was initially reported that the patient's skin may have broke down while on the mattress.Follow-up submitted as further investigation determined this complaint is only for the mattress sagging.This would be an annoyance issue only as the patient would still be supported by secondary foam structures.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.This issue is not likely to cause or contribute to serious injury or death if it was to recur.
 
Event Description
It was reported by the user facility that the patient's skin may have broke down while on the mattress.It was also reported there may have been fluid ingress.There was patient involvement; however, no clinically relevant delay in treatment was reported.
 
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Brand Name
IMPRESSION MED SURG SURFACE
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
pravin betala
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key3714858
MDR Text Key4486264
Report Number0001831750-2014-02797
Device Sequence Number1
Product Code IKY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/04/2014
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 Other
Device Catalogue Number2981000997
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/04/2014
Initial Date FDA Received03/31/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/11/2014
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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