EXCIMER 308

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-01 for EXCIMER 308 manufactured by Alma Lasers Gmbh.

Event Text Entries

[46324613] The suspected device excimer 308,was used on a patient for indication of cutaneous lymphoma in (b)(6) 2015. Based on the facility notes the patient sustained blisters everywhere and did not return for a follow up. The adverse event was reported after almost a year of the actual incident. This led to delays in collecting pertinent data. Inadequate data resulted in delayed processing of this adverse event. The customer has not seen the patient since the initial treatment and does not have any photos for a diagnosis to be made by an expert. The patient only called to report blisters. He did not return for a follow up. In absence of any adequate information , alma lasers inc. Is reporting this event in good faith efforts. Alma lasers inc. Also investigated the device and found it within recommended specifications. Per the clinical expert the treatment settings (200mj) used with the device is within recommended settings/protocol typically used for dermatoses(i. E. Psoriasis). However this device was used for off label along with large number of pulses that may suggest root cause of the blisters reported by the patient. It was a protocol deviation and misuse of the device that may have contributed to the adverse event. A letter to doctor will be sent to reiterate the importance of recommended protocol and indications for use.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3004450661-2016-00001
• MDR Report Key: 5692408
• Date Received: 2016-06-01
• Date of Report: 2016-03-12
• Date of Event: 2015-07-10
• Date Facility Aware: 2016-03-12
• Report Date: 2016-05-31
• Date Reported to FDA: 2016-05-31
• Date Reported to Mfgr: 2016-04-20
• Date Added to Maude: 2016-06-01
• Event Key: 0
• Report Source Code: Distributor 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: 3

Device Details

• Brand Name: EXCIMER 308
• Generic Name: ULTRAVIOLET LAMP
• Product Code: FTC
• Date Received: 2016-06-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 1 YR
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ALMA LASERS GMBH
• Manufacturer Address: NORDOSTPARK 100-102 NUERNBERG, BAYERN 90411 GM 90411

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2016-06-01