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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Headache (1880)
Event Date 07/09/2021
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 that 4 out of 5 surgeons used the duo headlight (90620us) and complained of headaches and migraines after use.At this time, no further information has been provided.
 
Manufacturer Narrative
90620us duo headlight was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The issue reported by the customer could not be determined.However, the issue of headaches may be the result of improper headband adjustment.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 Key12291495
MDR Text Key265572760
Report Number2523190-2021-00169
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 08/26/2021
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 Number90620US
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/15/2021
Initial Date FDA Received08/06/2021
Supplement Dates Manufacturer Received08/19/2021
Supplement Dates FDA Received08/26/2021
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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