DAAVLIN 7 SERIES

Additional Manufacturer Narrative

WE, THE MANUFACTURER HAVE INVESTIGATED THE REPORTED INCIDENT. THE DEVICE WAS FOUND TO HAVE BEEN PURCHASED VIA AN UNAUTHORIZED THIRD-PARTY (THRIFT STORE) AND USED BY A CONSUMER WITHOUT MEDICAL PRESCRIPTION OR SUPERVISION, AS SHOW ON THE LABELS. THE PATIENT REPORTED USING THE DEVICE FOR A DURATION EXCEEDING THE MAXIMUM RECOMMENDED EXPOSURE TIME, HAVING MISINTERPRETED THE MEDICAL DEVICE AS A CONSUMER TANNING UNIT. INVESTIGATION OF THE DEVICE (OR DEVICE RECORDS) INDICATES THE DEVICE FUNCTIONED ACCORDING TO SPECIFICATIONS. NO DEVICE MALFUNCTION WAS IDENTIFIED. THE EVENT IS ATTRIBUTED TO OFF-LABEL MISUSE.

Description of Event or Problem

THIS IS IN RESPONSE TO PREVIOUSLY FILED MAUDE REPORT MW5180372. PATIENT PURCHASED DEVICE FROM THRIFT STORE THAT ADVERTISED IT AS A TANNING BED, AND RECOMMENDED A 6 MINUTE TREATMENT TIME. PATIENT FELT UNCOMFORTABLE "SEVERAL MINUTES" INTO TREATMENT, AND EXPERIENCED SIGNIFICANT ERYTHEMA 12 HOURS LATER, LEADING THE PATIENT, IN CONFUSION, TO SEEK MEDICAL TREATMENT.