MAUDE MDR 7596958

MDR report key
7596958
Report number
1226354-2018-00013
Event key
0
Event type
3
Date of event
2018-05-07
Date received
2018-06-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
25 UPTON DRIVE WILMINGTON MA 01887 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY LLLUMINATORBLU-UDUSA PHARMACEUTICALS, LNC.MVFD2009003570* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-06-1301. H

Event Narratives#

N

Patient 1

REPORTER STATED THAT PATIENT HAD A PDT TREATMENT AND DOES NOT REMEMBER DRIVING HIMSELF HOME. FOLLOW-UP ((B)(6)2018; (B)(6) 2018): NO SIGNIFICANT INFORMATION WAS RECEIVED. FOLLOW-UP ((B)(6) 2018; (B)(6) 2018): REPORTER STATED THAT PATIENT HAD LEVULAN PDT REACTION. UPON RECEIPT OF THIS INFORMATION, CASE BECAME VALID. FOLLOW-UP ((B)(6) 2018; (B)(6) 2018): NO SIGNIFICANT INFORMATION WAS RECEIVED. FOLLOW-UP ((B)(6) 2018; (B)(6) 2018): REPORTER STATED THE PATIENT HAD SEVERE SUN DAMAGE, SO HE WAS INCUBATED FOR 1 HOUR. THE PATIENT WAS BARELY ABLE TO STAY UNDER THE BLU-U FOR 30 SECONDS BECAUSE HE WAS IN SO MUCH PAIN AFTER BEING PLACED UNDER IT. AFTER TREATMENT THE PATIENT HAD GONE HOME AND MENTIONED TO HIS WIFE THAT HE DOESN'T REMEMBER HOW HE HAD GOTTEN HOME, WHICH THE REPORTER REFERRED TO AS TEMPORARY TRANSIENT APHASIA. THE REPORTER MENTIONED THAT THE OFFICE RECEIVED PICTURES OF THE PATIENT'S PROGRESS WITH TREATMENT AND THAT HE EXPERIENCED A NORMAL REACTION OF SCABBING. FOLLOW-UP ((B)(6) 2018; (B)(6) 2018): NO SIGNIFICANT INFORMATION WAS RECEIVED. FOLLOW-UP ((B)(6) 2018; (B)(6) 2018): NO SIGNIFICANT INFORMATION WAS RECEIVED. FOLLOW-UP ((B)(6) 2018; (B)(6) 2018): NO ADVERSE EVENT RELATED SIGNIFICANT INFORMATION WAS RECEIVED.

D

Patient 1

MEMORY IMPAIRMENT. REACTION NONSPECIFIC. WRONG TECHNIQUE IN DRUG USAGE PROCESS. PAIN. TRANSIENT APHASIA. SCABBING.