MAUDE Adverse Event Report: DAAVLIN DISTRIBUTING CO. DAAVLIN 7 SERIES; PHOTOTHERAPY UNIT

Model Number 7 SERIES

Device Problems Use of Device Problem (1670); Output Problem (3005)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

The device manufacturer discussed with the patient that they needed to receive dosing instructions from their doctor.The operations manual clearly states "erythema can result in as little as 15 seconds of exposure to uvb light.Prior to using your home phototherapy unit, contact your prescribing physician for specific treatment instructions and dosing information." the doctor stated the patient treated themselves for 6 minutes prior to talking with their doctor.The treatment should have been for 22 seconds.The manufacturer attempted to contact the patient by phone and email with no return calls or emails from the patient.

Event Description

The patient received an overdose of uvb nb resulting in erythema and blistering.

• Brand Name: DAAVLIN 7 SERIES
• Type of Device: PHOTOTHERAPY UNIT
• Manufacturer (Section D): DAAVLIN DISTRIBUTING CO.; 205 w. bement street; bryan, oh
• Manufacturer Contact: phil reece ; 205 w. bement; bryan, oh ; 6366304
• MDR Report Key: 10549854
• MDR Text Key: 207425734
• Report Number: 1526255-2020-00001
• Device Sequence Number: 1
• Product Code: FTC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 7 SERIES
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR