Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO TREATMENT RECLINER; CHAIR, EXAMINATION AND TREATMENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER MEDICAL-KALAMAZOO TREATMENT RECLINER; CHAIR, EXAMINATION AND TREATMENT Back to Search Results
Catalog Number 3500000710
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Fall (1848); Injury (2348)
Event Date 06/02/2016
Event Type  malfunction  
Event Description
It was reported that a larger patient was sitting in chair with footrest up but the footrest was having difficulty staying up.A physical therapist reportedly tried to keep the footrest up with a trash can.When the patient leaned forward to scratch her leg, the whole chair fell forward, allegedly throwing the patient out.It was reported the patient fell and hit her head, and had a large bump on her head.She had a ct scan done and the results came back clear.
 
Manufacturer Narrative
Supplemental submitted with results of evaluation.
 
Event Description
It was reported that a larger patient was sitting in chair with footrest up but the footrest was having difficulty staying up.A physical therapist reportedly tried to keep the footrest up with a trash can.When the patient leaned forward to scratch her leg, the whole chair fell forward, allegedly throwing the patient out.It was reported the patient fell and hit her head, and had a large bump on her head.She had a ct scan done and the results came back clear.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TREATMENT RECLINER
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 Key5808667
MDR Text Key50909820
Report Number0001831750-2016-00231
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number3500000710
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-