DUO HEADLIGHT 2 BAY SYSTEM - US
Received Aug 25, 2019 · Event occurred Jul 20, 2019
Report 2523190-2019-00102 · MDR key 8928806
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Headache
- Pain
- Headache
- Pain
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION RECEIVED ON 17SEP2019 AND 09OCT2019 REPORTED THAT THE HEADLIGHT WAS UNCOMFORTABLE, HURT THE DOCTOR¿S HEAD AND GAVE HIM A HEADACHE. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. LOT NUMBER/SERIAL NUMBER NOT RECEIVED TO PERFORM DEVICE HISTORY RECORD REVIEW. A FAILURE ANALYSIS AND DETERMINATION OF ROOT CAUSE IS NOT POSSIBLE DUE TO PRODUCT HAS NOT BEEN RETURNED. THE REPORTED COMPLAINT IS UNCONFIRMED. DEVICE IDENTIFIER: (B)(4).
Additional Manufacturer Narrative
THE DEVICE NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
A PHYSICIAN REPORTED AND DESCRIBED THAT ON (B)(6) 2019, THE 90620US DUO HEADLIGHT 2 BAY SYSTEM ¿ US, CAUSED PAIN ON THE TOP OF HIS HEAD WHERE THE PADDING OF THE DUO HEADLIGHT ADJUSTMENT KNOB MET ON HIS HEAD DURING A PLASTIC SURGERY. THE DOCTOR REPORTED THAT AFTER WEARING THE DEVICE FOR ONE HOUR THE PAIN WAS SEVERE ENOUGH THAT HE HAD TO TAKE THE LIGHT OFF AND THAT HE DEVELOPED A HEADACHE AND FELT A SORE SPOT ON HIS HEAD FOR SEVERAL HOURS AFTERWARDS. ATTEMPTS TO REFIT THE HEADLIGHT ON HIS HEAD WERE MADE INCLUDING USING THE FIT GUIDE, HOWEVER, THE ISSUE DID NOT RESOLVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.