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

Model Number	0015803
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while loading a patient into the ambulance the medic alleged they felt a pop in their left hand that did not cause pain but felt as if something was out of place.The report indicated the medic did seek medical evaluation; however, no further details were provided.The complainant stated there was no indication in the injury claim that the stretcher malfunctioned in any way and that the alleged injury was related to the medic's lifting technique.

• Brand Name: INX FOR INLINE
• Common Device Name: INX FOR INLINE
• Manufacturer (Section D): FERNO-WASHINGTON, INC.; 70 weil way; wilmington OH 45177
• MDR Report Key: 8048382
• Report Number: 1523574-2018-00036
• Device Sequence Number: 11214183
• Product Code: FPO
• UDI-Device Identifier: 00190790000004
• UDI-Public: 00190790000004
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0015803
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other