DUO HEADLIGHT AND CARRYING CASE
Received Feb 24, 2021
Report 2523190-2021-00037 · MDR key 11376571
Device
Generic name
Pfm05
Catalog number
90600
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
DUO HEADLIGHT (90600) WAS NOT RETURNED FOR EVALUATION (CUSTOMER STATED THAT THE PRODUCT WILL NOT BE RETURNED) 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. THIS ISSUE MAY BE THE RESULT OF CUSTOMER PREFERENCE. 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.
Additional Manufacturer Narrative
ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
A FACILITY REPORTED THAT THEY ARE UNHAPPY WITH THE COMFORT OF THE DUO HEADLIGHTS (90600) AS THEY ARE CAUSING PAIN AND HEADACHES. WHEN THEY REMOVE THE FRONT PAD, IT FEELS A LOT BETTER. NO DELAY IN PROCEDURE WAS REPORTED.