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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; RECLINING CHAIR
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STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; RECLINING CHAIR Back to Search Results
Catalog Number UNK_MED
Device Problem Use of Device Problem (1670)
Patient Problems Pain (1994); No Patient Involvement (2645)
Event Date 10/29/2019
Event Type  Injury  
Event Description
It was reported that a staff member did not lock the brakes on a trurize chair and it rolled into her leg.It was reported that the staff member was injured and is using crutches.
 
Manufacturer Narrative
It was reported that the staff member did not lock the brakes of the unit, resulting in the unit rolling into her leg.Device was not available for evaluation.
 
Event Description
It was reported that a staff member did not lock the brakes on a trurize chair and it rolled into her leg.It was reported that the staff member was injured and is using crutches.Multiple attempts were made to the customer for further details pertaining to the injury, however they could not be reached.
 
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Brand Name
UNKNOWN_MEDICAL_PRODUCT
Type of Device
RECLINING CHAIR
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
kelsey barla
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key9371942
MDR Text Key167970842
Report Number0001831750-2019-01214
Device Sequence Number1
Product Code INO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2019
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
Is the Reporter a Health Professional? No
Date Manufacturer Received10/29/2019
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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