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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 Slipped (1584)
Patient Problem Fall (1848)
Event Date 10/10/2014
Event Type  malfunction  
Event Description
It was reported a patient fell from the recliner when the footrest experienced a false latch situation.
 
Event Description
It was reported a patient fell from the recliner when the footrest experienced a false latch situation.
 
Manufacturer Narrative
Unit involved in the alleged incident could not be identified by the account, therefore no inspection was performed.
 
Manufacturer Narrative
The user facility was able to identify the unit involved in the alleged complaint (serial number (b)(4)); it was evaluated and found to be working to specification.
 
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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
mary klaver
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key4235928
MDR Text Key4996666
Report Number0001831750-2014-03325
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 Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number3500000730
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/10/2014
Initial Date FDA Received11/07/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/12/2015
Was Device Evaluated by Manufacturer? Yes
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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