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U.S. Department of Health and Human Services

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

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DUO HEADLIGHT 2 BAY SYSTEM - US; PFM05 Back to Search Results
Catalog Number 90620US
Device Problem Defective Device (2588)
Patient Problem Headache (1880)
Event Date 10/19/2020
Event Type  Injury  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A facility reported the duo headlight was used for a spinal decompression on (b)(6) 2020.The surgeon started getting headache 30 minutes into the case and used the unit for a total of one (1) hour before having to take off and adjust to a thinner 1.5 led padding with no improvement.The surgeon said that the padding in front was pressing against his temples just above his eyebrows and thought that the duo balance was more front loaded feeling like the headlight would continue to come forward.The surgeon rated his headache as 7 from a scale of 1 to 10, and felt better when he took off the duo headlight.
 
Manufacturer Narrative
Unique device identifier (udi): (b)(4).Duo headlight was not returned (customer declined to return the product for failure analysis); therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
 
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Brand Name
DUO HEADLIGHT 2 BAY SYSTEM - US
Type of Device
PFM05
MDR Report Key10852425
MDR Text Key216627702
Report Number2523190-2020-00135
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,user f
Type of Report Initial,Followup
Report Date 10/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number90620US
Device Lot NumberL000266
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/19/2020
Initial Date FDA Received11/17/2020
Supplement Dates Manufacturer Received12/07/2020
Supplement Dates FDA Received12/24/2020
Date Device Manufactured04/17/2019
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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