MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 35-X PROFLEXX

Model Number 0015693

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Unspecified Tissue Injury (4559)

Event Date 09/06/2021

Event Type  Injury  

Event Description

The complainant reported while rolling the stretcher between the patient's residence and the ambulance, a wheel rolled off of the pavement edge and the stretcher tipped over.The patient allegedly sustained injury consisting of hip pain from a previous fall and was seen in the er.No further details were provided.

Event Description

The complainant reported while rolling the stretcher between the patient's residence and the ambulance, a wheel rolled off of the pavement edge and the stretcher tipped over.The patient allegedly sustained injury consisting of hip pain from a previous fall and was seen in the er.No further details were provided.

Manufacturer Narrative

The device was evaluated by an authorized repair technician.The technician function tested the unit with no device issues found that would have contributed to the alleged incident.The customer has not provided any further details pertaining to the patient injury or medical intervention sought.

• Brand Name: 35-X PROFLEXX
• Type of Device: 35-X PROFLEXX
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• Manufacturer (Section G): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• Manufacturer Contact: dawn greene ; 70 weil way; wilmington, OH 45177 ; 9372832800
• MDR Report Key: 12460852
• MDR Text Key: 271065823
• Report Number: 1523574-2021-00015
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0015693
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2012
• 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
• Patient Sex: Male
• Patient Weight: 111 KG