FDA.reportPublic FDA data

MAUDE MDR 25006453

MDR report key
25006453
Report number
3031944951-2026-00004
Event key
0
Event type
3
Date of event
2026-03-31
Date received
2026-04-27
Adverse event
0
Product problem
1
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
0

Manufacturer Contact#

Contact
MS SANDRA HANSEN
Address
121 CITATION COURT HOMEWOOD 35209 US
Phone
925-925-9255
Report source
M

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
575799SPECTRUMPOWERED LASER SURGICAL INSTRUMENTROHRER AESTHETICS, INC.GEXSPECTRUMYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12026-04-270

Event Narratives#

N

Patient 0

THE DEVICE WAS REPLACED AT USER FACILITY. FULL SET OF TESTING WAS DONE AFTER AFFECTED DEVICE WAS RETURNED TO MANUFACTURING FACILITY AND THE PROBLEM COULD NOT BE DUPLICATED. THE SYSTEM PASSED ALL TESTS. AN ARO FORM FDA 2649 WAS SUBMITTED ON 4/27/26.

D

Patient 0

USER RECEIVED AN ELECTRICAL SHOCK FROM THE HANDPIECE OF THE SPECTRUM DEVICE AFTER INSTALLING A REPLACEMENT PART. THE USER INSTALLED A REPLACEMENT PART ONTO THE UNIT, MADE CONTACT WITH THE COOLING PLATE ON THE HANDPIECE TO ASSESS WHETHER COOLING WAS FUNCTIONING PROPERLY. UPON CONTACT, THE USER REPORTED EXPERIENCING AN ELECTRICAL SHOCK IN THE HAND, WITH SENSATION TRAVELING UP THE ARM AND INTO THE CHEST. IMMEDIATELY AFTER THE INCIDENT, THE USER REPORTED FEELING LIGHTHEADED AND DIZZY. THE USER PRESENTED TO THE EMERGENCY ROOM, WHERE AN EKG WAS PERFORMED WITH NORMAL RESULTS AND NO ADDITIONAL ABNORMALITIES IDENTIFIED. THE USER REPORTED THAT THE SHCOK DID NOT RESULT IN ANY VISIBLE SKIN DAMAGE AND THERE WAS NO BURN MARKS PRESENT.