MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO TREATMENT RECLINER; CHAIR, EXAMINATION AND TREATMENT

Catalog Number 3500000710

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Headache (1880)

Event Date 09/13/2016

Event Type  Injury  

Event Description

It was reported that the user got out of the recliner at night, and upon re-entering the recliner, accidentally sat on the ottoman and began to fall down.The spring in the ottoman pushed the user's weight upwards and the user fell forward out of the chair.During the fall forward out of the chair, the patient hit her hand on a computer keyboard and hit her head on another object in the room while falling.It was reported that she fractured her ring finger and had a headache from the fall that she treated by taking tylenol.No further details regarding the injury or medical intervention was reported.Upon inspection by a stryker service rep, no defect was found with the recliner.

• 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: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6015588
• MDR Text Key: 56927930
• Report Number: 0001831750-2016-00312
• Device Sequence Number: 1
• Product Code: FRK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 3500000710
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1