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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; CHAIR, EXAMINATION AND TREATMENT
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STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; CHAIR, EXAMINATION AND TREATMENT Back to Search Results
Catalog Number UNK_MED
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/19/2014
Event Type  malfunction  
Event Description
It was reported via repair work order that the recliner was broken down the middle.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Event Description
It was reported via repair work order that the recliner was broken down the middle.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Follow-up submitted as further investigation determined the recliner bed is not a medical device and, therefore, no reporting is required.
 
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Brand Name
UNKNOWN_MEDICAL_PRODUCT
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
pravin betala
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key3685391
MDR Text Key4299603
Report Number0001831750-2014-02402
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 02/19/2014
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 NumberUNK_MED
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/19/2014
Initial Date FDA Received03/18/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/07/2014
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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