MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PROCUITY LEX WITH ISOTOUR STD; BED, AC POWERED, ADJUSTABLE HOSPITAL

Model Number 3009PX-LEX-400

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/28/2022

Event Type  Injury  

Event Description

It was reported that a nurse tripped over the siderail leading to an elbow fracture which required surgical intervention.Upon evaluation, no issues were found with the product.

• Brand Name: PROCUITY LEX WITH ISOTOUR STD
• Type of Device: BED, AC POWERED, ADJUSTABLE HOSPITAL
• 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 15600879
• MDR Text Key: 301722205
• Report Number: 0001831750-2022-00931
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327541229
• UDI-Public: 07613327541229
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 3009PX-LEX-400
• Device Catalogue Number: 3009PX-LEX-400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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