MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME TC SWING-AWAY MODEL; CHAIR, ADJUSTABLE, MECHANICAL

Catalog Number 1460000000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 10/11/2016

Event Type  malfunction  

Event Description

It was alleged that during patient transport the foot rest did not support the weight of the patients foot and allegedly the patients foot dropped to the ground.It was alleged that the patient experienced some pain from the alleged event, however no medical intervention or serious injury was reported.

Manufacturer Narrative

This issue was resolved for the customer by filing a complaint to document the issue.

Event Description

It was alleged that during patient transport the product hit a bump, which allegedly caused the patient's foot to drop to the ground.It was alleged that the patient experienced some pain from the alleged event, however no medical intervention or serious injury was reported.Upon further investigation it was found that no defect was alleged with the product.

Manufacturer Narrative

Supplemental submitted to include udi.

Event Description

It was alleged that during patient transport the product hit a bump, which allegedly caused the patient's foot to drop to the ground.It was alleged that the patient experienced some pain from the alleged event, however no medical intervention or serious injury was reported.Upon further investigation it was found that no defect was alleged with the product.

• Brand Name: PRIME TC SWING-AWAY MODEL
• Type of Device: CHAIR, ADJUSTABLE, MECHANICAL
• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6090016
• MDR Text Key: 59897432
• Report Number: 0001831750-2016-00344
• Device Sequence Number: 1
• Product Code: INN
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1460000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2016
• 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