MAUDE Adverse Event Report: NATIONAL BIOLOGICAL CORPORATION FOLDALITE III 32 LAMP; PHOTOTHERAPY UNIT

Model Number UVB-832

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Blister (4537)

Event Date 08/11/2021

Event Type  Injury  

Manufacturer Narrative

National biological investigated the incident and found the following information.While it is the physician's choice on the patient's treatment dosages, it was found that the patient dosage was more than double of the recommended dosage listed in the ifu.The shelk & morgan protocol, referenced in our ifu, recommends a skin type of i to be treated at 520 mj/cm2 as a goal dosage.The patient (has a skin type of i) was being treated at 1375 mj/cm2.Standard protocol also recommends a dosage decrease of as much of 50% once erythema occurs, this did not occur in this instance.

Event Description

Patient experienced overtreatment at a clinic.The patient received phototherapy treatments for > 1 year at this clinic.The patient blistered after one of their treatments and was treated with prescription strength hydrocortisone.The treatment was more than double the dose recommended in the operations manual.

• Brand Name: FOLDALITE III 32 LAMP
• Type of Device: PHOTOTHERAPY UNIT
• Manufacturer (Section D): NATIONAL BIOLOGICAL CORPORATION; 23700 mercantile road; beachwood OH 44122
• Manufacturer (Section G): NATIONAL BIOLOGICAL CORP; 23700 mercantile road; beachwood OH 44122
• Manufacturer Contact: national biological corp ; 23700 mercantile road; beachwood, OH 44122 ; 2168310600
• MDR Report Key: 12413573
• MDR Text Key: 271465939
• Report Number: 1521608-2021-00002
• Device Sequence Number: 1
• Product Code: FTC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K827890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/02/2021

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 Model Number: UVB-832
• Device Catalogue Number: UVB-832
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other