MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PATIENT ROOM WALL SAVER RECL; CHAIR, EXAMINATION AND TREATMENT

Catalog Number 3500000730

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Fall (1848)

Event Date 04/16/2016

Event Type  malfunction  

Manufacturer Narrative

Unable to locate recliner in order to perform evaluation.

Event Description

It was reported that the recliner would not shut all the way and a patient allegedly fell trying to exit the chair.The recliner was not able to be located in order to perform an evaluation and no additional information has been provided.

Manufacturer Narrative

Supplemental submitted to provide the information that the patient reportedly sustained abrasions to her knees, but required no major medical intervention.

Event Description

It was reported that the recliner would not shut all the way and a patient allegedly fell trying to exit the chair.The recliner was not able to be located in order to perform an evaluation and no additional information has been provided.

• 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 Key: 5656751
• MDR Text Key: 45237222
• Report Number: 0001831750-2016-00164
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2016

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 Number: 3500000730
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/17/2016
• Initial Date FDA Received: 05/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2016
• 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 Number: 1