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

Catalog Number 1460000000

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

Patient Problems Fall (1848); Injury (2348)

Event Date 05/04/2017

Event Type  Injury  

Event Description

It was alleged that a user fell from the device and possibly broke their foot.

Manufacturer Narrative

The user facility was contacted for further information regarding this event and they reported that there has not been any prime tc related incidents in their reporting system.Device could not be identified.

Event Description

It was alleged that a user fell from the device and possibly broke their foot.

Manufacturer Narrative

Supplemental submitted to include udi.Device could not be identified.

Event Description

It was alleged that a user fell from the device and possibly broke their foot.

• 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: 6609554
• MDR Text Key: 76571141
• Report Number: 0001831750-2017-00218
• 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: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 1460000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2017
• 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