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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PATIENT ROOM WALL SAVER RECL; CHAIR, EXAMINATION AND TREATMENT
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STRYKER MEDICAL-KALAMAZOO PATIENT ROOM WALL SAVER RECL; CHAIR, EXAMINATION AND TREATMENT Back to Search Results
Catalog Number 3500000730
Device Problem Device Fell (4014)
Patient Problems Fall (1848); Pain (1994)
Event Date 09/09/2019
Event Type  malfunction  
Event Description
The customer alleges that the back of the recliner fell backwards and the patient fell on the floor.The patient was sent to the emergency room for an evaluation of their back, lower back, and neck.Further information has not been provided.
 
Manufacturer Narrative
The patient was sent to the er as a precaution for neck and back pain but incurred no injuries as a result of the fall.
 
Event Description
The customer alleges that the back of the recliner fell backwards and the patient fell on the floor.The patient was sent to the emergency room for an evaluation of their back, lower back, and neck.
 
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Brand Name
PATIENT ROOM WALL SAVER RECL
Type of Device
CHAIR, EXAMINATION AND TREATMENT
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 Key9157573
MDR Text Key163218398
Report Number0001831750-2019-00920
Device Sequence Number1
Product Code FRK
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 11/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number3500000730
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received09/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2019
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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