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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 broken 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.
 
Event Description
It was reported by the user facility that the patient's skin may have broken 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 by the user facility that the patient's skin may have broken down while on the mattress and that there may have been fluid ingress.Follow-up submitted to report that it was further reported that the mattress was sagging in the center section and this was alleged to have contributed to an increase in stages 1 and 2 pressure ulcers at the facility.However, no specific mattresses or serial number associated with the alleged pressure ulcers was recorded.Also, documentation showing the alleged increase in pressure ulcers at the facility could not be provided.Issue was resolved by informing the customer of the replacement process.Evaluation performed by customer.
 
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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 Key3714684
MDR Text Key4332257
Report Number0001831750-2014-02798
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 Received04/14/2014
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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