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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERNO-WASHINGTON, INC. 65 SCOOP STRETCHER
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FERNO-WASHINGTON, INC. 65 SCOOP STRETCHER Back to Search Results
Model Number 0108037
Device Problems Device Difficult to Setup or Prepare (1487); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Date 11/09/2016
Event Type  No Answer Provided  
Event Description
We received a report from a distributor that their customer was operating the scoop stretcher and a medic was allegedly cut on a sharp edge.It was noted there was no injury to the patient.Details on the alleged injury and any required medical intervention was not provided in the initial report.This incident will be further investigated.
 
Manufacturer Narrative
The complainant provided an incident report clarifying they experienced difficulty in extending the stretcher into position and they believed there to be some type of grinding when opening and closing the stretcher.The scoop stretcher was returned and a visual and functional evaluation was conducted.The unit was laid flat on a table and was then cycled open and closed with no issues.Multiple scratches and dents were observed on the stretcher.The stretcher was also reviewed for any sharp edges; however, no sharp edges were found.The reported complaint could not be duplicated and it is unknown how the emt allegedly cut his hand on the stretcher.A follow up communication was made to the emt and he stated the lacerations were superficial in nature and he did not seek any medical intervention.
 
Event Description
We received a report from a distributor that their customer was operating the scoop stretcher and a medic was allegedly cut on a sharp edge.It was noted there was no injury to the patient.Details on the alleged injury and any required medical intervention was not provided in the initial report.This incident will be further investigated.
 
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Brand Name
65 SCOOP STRETCHER
Type of Device
65 SCOOP STRETCHER
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 Key6132421
MDR Text Key61047711
Report Number1523574-2016-00033
Device Sequence Number1
Product Code FPP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/30/2017
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
Device Operator Emergency Medical Technician
Device Model Number0108037
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/16/2016
Initial Date FDA Received11/29/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/31/2017
Was Device Evaluated by Manufacturer? Yes
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 Age66 YR
Patient Weight95
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