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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; BED, PATIENT ROTATION, POWERED
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STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; BED, PATIENT ROTATION, POWERED Back to Search Results
Catalog Number UNK_MED
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Pressure Sores (2326); Tissue Breakdown (2681)
Event Date 01/21/2020
Event Type  Injury  
Event Description
It was reported that a patient acquired a deep tissue injury and stage 4 pressure injury while laying on a stryker mattress.No further information about the injuries or treatments for those injuries was reported.Attempts have been made to reach the customer for more information; however, the customer has not responded to these attempts.
 
Event Description
It was reported that a patient acquired a deep tissue injury and stage 4 pressure injury while laying on a stryker mattress.No further information about the injuries or treatments for those injuries was reported.Attempts have been made to reach the customer for more information; however, the customer has not responded to these attempts.
 
Manufacturer Narrative
The user facility did not respond to stryker's attempts for further information regarding the reported malfunction and injury.
 
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Brand Name
UNKNOWN_MEDICAL_PRODUCT
Type of Device
BED, PATIENT ROTATION, POWERED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key9752998
MDR Text Key180902678
Report Number0001831750-2020-00304
Device Sequence Number1
Product Code IKZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 05/04/2020
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 NumberUNK_MED
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/28/2020
Initial Date FDA Received02/26/2020
Supplement Dates Manufacturer Received01/28/2020
Supplement Dates FDA Received05/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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