LEVIA PHOTOTHERAPY SYSTEM LH-75 T

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-18 for LEVIA PHOTOTHERAPY SYSTEM LH-75 T manufactured by Daavlin.

Event Text Entries

[32240609] I was a distributor for lerner medical devices and sold some levias to medical clinics abroad. Daavlin (daavlin. Com) purchased lerner medical devices last year. I sent the levia device s/n (b)(4) to be repaired to daavlin this year (www. Daavlin. Com). They charged around (b)(6) dollars for the repair. The device came with no labels, neither repaired properly, no test of safety on the device was provided, no information on the work performed or maintenance or stating the product was ready and safe to be used again. After testing the product, the unit presents the same problems that we paid and sent the instrument to be repaired initially. I talked to the company and they want more money to fix the problem. I am reporting the safety issue and the lack of iso quality and safety regulations followed by daavlin (daavlin. Com) demonstrated on the repair of this particular product called levia model lh-75 phototherapy system. This product is regulated by the fda as a prescription device and it should be monitored as other clients are complaining about the same issue.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5058014
• MDR Report Key: 5243456
• Date Received: 2015-11-18
• Date of Report: 2015-11-18
• Date of Event: 2015-06-10
• Date Added to Maude: 2015-11-23
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: LEVIA PHOTOTHERAPY SYSTEM
• Generic Name: LEVIA PHOTOTHERAPY SYSTEM
• Product Code: FTC
• Date Received: 2015-11-18
• Model Number: LH-75 T
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DAAVLIN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2015-11-18