MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO TRURIZECLINICAL CHAIR; CHAIR, POSITIONING, ELECTRIC

Catalog Number 3333000000

Device Problems Material Too Rigid or Stiff (1544); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pressure Sores (2326); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2023

Event Type  Injury  

Event Description

The customer alleged that the trurize chair had caused pressure injuries.Attempts are being made to gather additional details from the user facility.

Manufacturer Narrative

It was reported that there has been a general increase in pressure injuries.Multiple attempts were made to gather the number of injuries, extent of the injuries, the treatment information, and resolution.However, the customer did not respond, and no additional information was gained.The alleged injuries could not be directly tied to any defect or malfunction with the product.After investigation, it was determined that the alleged increase in pressure injuries was not caused or contributed to by the trurize chairs, as no malfunction was alleged with the devices.

Event Description

It was reported that there has been a general increase in pressure injuries.There was patient involvement, but no serious injury, adverse consequence, or clinically relevant delay in treatment was reported.

Event Description

It was reported that the device's hard surfaces generate pressure.There was patient involvement, but no serious injury, adverse consequence, or clinically relevant delay in treatment was reported.

Manufacturer Narrative

It was reported that the device's hard surfaces generate pressure was most likely not related to any component-level defect or malfunction.However, this could not be confirmed.In addition, a stryker qae spoke to a stryker sales account manager, who provided contact information for the wound care nurse who reported the complaint.Several attempts were made to obtain more information regarding the alleged events, including the number of injuries, extent of the injuries, treatment of the injuries, or resolution.However, the customer did not respond, and no additional information was gained.Based on the information provided, the alleged injuries could not be directly tied to any defect or malfunction with the product.

• Brand Name: TRURIZECLINICAL CHAIR
• Type of Device: CHAIR, POSITIONING, ELECTRIC
• 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: alex wibert ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17628753
• MDR Text Key: 322022309
• Report Number: 0001831750-2023-00986
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 07613327322569
• UDI-Public: 07613327322569
• 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: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 3333000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/08/2017
• 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