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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 28-Z COT
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FERNO-WASHINGTON, INC. 28-Z COT Back to Search Results
Model Number 0012810
Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Tissue Damage (2104)
Event Type  Injury  
Event Description
The complainant reported while transporting a patient on the stretcher, the patient allegedly sustained a finger amputation after inserting their finger in an area outside of the patient surface.No further details or information have been provided regarding the alleged incident details, the degree of the finger amputation sustained by the patient or required medical intervention.
 
Manufacturer Narrative
The complainant has provided no additional details on the alleged incident and has not made the stretcher available for evaluation by the manufacturer.There has been no allegation of product malfunction being a factor in the alleged incident.The stretcher has been in the field for 8+ years.The ifu contains instructions for proper use of the stretcher while transporting a patient.
 
Event Description
The complainant reported while transporting a patient on the stretcher, the patient allegedly sustained a finger amputation after inserting their finger in an area outside of the patient surface.No further details or information have been provided regarding the alleged incident details, the degree of the finger amputation sustained by the patient or required medical intervention.
 
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Brand Name
28-Z COT
Type of Device
28-Z COT
Manufacturer (Section D)
FERNO-WASHINGTON, INC.
70 weil way
wilmington, oh OH 45177
MDR Report Key9629324
MDR Text Key179545982
Report Number1523574-2020-00004
Device Sequence Number1
Product Code FPO
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 03/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number0012810
Was Device Available for Evaluation? No
Date Manufacturer Received01/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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