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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 Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/17/2017
Event Type  malfunction  
Event Description
It was reported that the footrest extends too quickly, due to a bent recliner mechanism.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Event Description
It was reported that the footrest extends too quickly, due to a bent recliner mechanism.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
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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 Key6616477
MDR Text Key76862143
Report Number0001831750-2017-00229
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 07/07/2017
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 No Information
Device Catalogue Number3500000730
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/17/2017
Initial Date FDA Received06/06/2017
Supplement Dates Manufacturer Received05/17/2017
Supplement Dates FDA Received07/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/05/2012
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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