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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DUO HEADLIGHT 2 BAY SYSTEM - AU; PFM05

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DUO HEADLIGHT 2 BAY SYSTEM - AU; PFM05 Back to Search Results
Catalog Number 90620AU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Headache (1880)
Event Date 08/18/2021
Event Type  Injury  
Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A facility reported that the surgeons find that the duo headlight 2 bay system (90620au) was too uncomfortable, causing headaches and dents in the forehead.No medical intervention was required.The surgeons experienced the headache once and stopped using the headlight system.There was no patient involvement; thus, no patient injury or surgical delay occurred.
 
Event Description
N/a.
 
Manufacturer Narrative
The duo headlight 2 bay system (90620au) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis: evaluation could not duplicate the issue of discomfort.However, it was found that the gears were slipping when the straps are pulled with moderate force.Adjustment due to wear/misalignment has been made to correct this issue.No manufacturing, workmanship, or material deficiency has been identified.Root cause: the returned 90620au headlight passed testing and met specifications.The issue of discomfort could not be duplicated.The reported issue may be the result of customer preference.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.
 
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Brand Name
DUO HEADLIGHT 2 BAY SYSTEM - AU
Type of Device
PFM05
MDR Report Key12445554
MDR Text Key270486851
Report Number2523190-2021-00201
Device Sequence Number1
Product Code FSR
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/30/2021
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 Health Professional
Device Catalogue Number90620AU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/06/2021
Initial Date Manufacturer Received 08/18/2021
Initial Date FDA Received09/09/2021
Supplement Dates Manufacturer Received09/28/2021
Supplement Dates FDA Received09/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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