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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 Consequences Or Impact To Patient (2199)
Event Date 05/04/2017
Event Type  malfunction  
Event Description
It was reported that the backrest was broken.Although not reported, this could lead to a situation where the recliner is unable to support patient weight.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
This complaint could not be confirmed as the customer was unable to locate the unit.
 
Event Description
It was reported that the backrest was broken.Although not reported, this could lead to a situation where the recliner is unable to support patient weight.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
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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
chanda burghard
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key6608961
MDR Text Key76688357
Report Number0001831750-2017-00217
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 08/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberUNK_MED
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received05/04/2017
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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