MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. INX FOR INLINE WITH DWL

Model Number 0015811

Device Problem No Apparent Adverse Event (3189)

Patient Problem Pain (1994)

Event Date 10/22/2021

Event Type  Injury  

Event Description

The customer reported the stretcher was involved in a motor vehicle accident while transporting a patient.The customer advised the stretcher remained locked within the fastener throughout the accident.There has been no allegation of a product malfunction.The patient is alleging back pain, solely, as a result of the motor vehicle accident.

Manufacturer Narrative

The device was evaluated by the customer with no product issues found.The patient alleged injury is being attributed to the motor vehicle accident.No further details were provided.

• Brand Name: INX FOR INLINE WITH DWL
• Type of Device: INX FOR INLINE WITH DWL
• 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 ; 9372832900
• MDR Report Key: 12762993
• MDR Text Key: 280450892
• Report Number: 1523574-2021-00016
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 00019090001339
• UDI-Public: 0019090001339
• 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
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0015811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2019
• 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