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

Model Number 1460-000-000

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Date 08/04/2021

Event Type  malfunction  

Event Description

It was reported that while transporting a patient, the chair hit a rug.The caregiver attempted to push the chair over the rug, and hurt their back.Attempts are being made to gather additional injury and treatment details.

Manufacturer Narrative

Upon follow up with a stryker clinical liaison it was determined that the back injury was not severe and did not require medical intervention.This issue is not reportable.Section b5 and section h have been updated.H3 other text: user facility did not respond to attempts to evaluate the device.

Event Description

It was reported that while transporting a patient, the chair hit a rug.The caregiver attempted to push the chair over the rug, and hurt their back.Multiple attempts were made to gather more information from the user facility; however, they did not respond to these attempts.A third attempt letter was sent to the customer.Upon follow up with a stryker clinical liaison it was determined that the back injury was likely not severe and was most likely treated with an over the counter medication.Based on this information, the alleged issue is not reportable.

Event Description

It was reported that while transporting a patient, the chair hit a rug.The caregiver attempted to push the chair over the rug, and hurt their back.Multiple attempts were made to gather more information from the user facility; however, they did not respond to these attempts.A third attempt letter was sent to the customer and a supplemental will be filed if additional information is provided.

Manufacturer Narrative

The user facility did not respond to attempts to evaluate the device, section h codes have been updated.H3 other text : user facility did not respond to attempts to evaluate the device.

• 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: kelsey barla ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 12392577
• MDR Text Key: 268957311
• Report Number: 0001831750-2021-01316
• Device Sequence Number: 1
• Product Code: INN
• UDI-Device Identifier: 07613327282665
• UDI-Public: 07613327282665
• 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: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 1460-000-000
• Device Catalogue Number: 1460000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2021
• 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
• Patient Outcome(s): Other