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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. MODEL 35X PROFLEXX STRETCHER
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FERNO-WASHINGTON, INC. MODEL 35X PROFLEXX STRETCHER Back to Search Results
Model Number 0015703
Device Problem Difficult to Fold, Unfold or Collapse (1254)
Patient Problems Bone Fracture(s) (1870); Swelling (2091)
Event Date 11/07/2014
Event Type  Injury  
Event Description
Upon unloading the stretcher from the ambulance, the medic attempted and was unable to lower the wheels.Upon repositioning of this hands he heard a pop in his wrist and noticed subsequent swelling.Treatment was sought but no details were provided.The medic has returned to work.
 
Manufacturer Narrative
The unit was evaluated by (b)(4), on behalf of mfr, on 11/13/2014.The unit passed all function tests with no issues.No malfunctions were detected and the incident could not be duplicated.
 
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Brand Name
MODEL 35X PROFLEXX STRETCHER
Type of Device
MODEL 35X PROFLEXX STRETCHER
Manufacturer (Section D)
FERNO-WASHINGTON, INC.
wilmington OH 45177
Manufacturer Contact
dawn greene
70 weil way
wilmington, OH 45177
9372832900
MDR Report Key4336002
MDR Text Key5177151
Report Number1523574-2014-00024
Device Sequence Number1
Product Code FPO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number0015703
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/07/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age26 YR
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