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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. INX, FOR INLINE
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FERNO-WASHINGTON, INC. INX, FOR INLINE Back to Search Results
Model Number 0015811
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Patient Problems Bruise/Contusion (1754); Swelling (2091)
Event Date 05/24/2019
Event Type  Injury  
Event Description
The complainant alleges the cot lowered unexpectedly while removing it from the ambulance.The medic alleges a bruise and swelling to the left arm as a result of the incident.No additional information has been provided pertaining to medical intervention sought.
 
Manufacturer Narrative
A visual and functional evaluation was conducted by an authorized technician.The technician found the cot to be functioning as intended.There were no observations that would have contributed to the alleged incident and the alleged issue could not be duplicated.The ifu provides clear instruction for maintaining control of the device at all times.
 
Event Description
The complainant alleges the cot lowered unexpectedly while removing it from the ambulance.The medic alleges a bruise and swelling to the left arm as a result of the incident.No additional information has been provided pertaining to medical intervention sought.
 
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Brand Name
INX, FOR INLINE
Type of Device
INX, FOR INLINE
Manufacturer (Section D)
FERNO-WASHINGTON, INC.
70 weil way
wilmington OH 45177
MDR Report Key8680275
MDR Text Key147381185
Report Number1523574-2019-00020
Device Sequence Number1
Product Code FPO
UDI-Device Identifier00190790001339
UDI-Public00190790001339
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 06/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number0015811
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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