FDA.reportPublic FDA data

MAUDE MDR 24807896

MDR report key
24807896
Report number
3031944951-2026-00003
Event key
0
Event type
3
Date of event
2026-02-20
Date received
2026-04-07
Adverse event
1
Product problem
0
Patients in event
0
Reporter occupation
501
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
33519SPECTRUMPOWERED LASER SURGICAL INSTRUMENTROHRER AESTHETICS, INC.GEXSPECTRUMNY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12026-04-070R

Event Narratives#

D

Patient 0

PATIENT RECEIVED HER FIRST TREATMENT FOR BIKINI LASER HAIR REMOVAL WITH SPECTRUM 810 DIODE LASER ON (B)(6) 2026. AFTER TREATMENT WAS DONE PATIENT SENT A PICTURE OF DARKENED SPOT IN THE BIKINI AREA TO PROVIDER ANDTHEY ADVISED APPLYING AQUAPHOR OR VASELINE AND REQUESTED SHE CALL BACK WITH ANY CONCERNS. (B)(6) PATIENT NOTIFIED PROIDER THAT SHE VISITED HER PCP AND URGENT CARE ON (B)(6) 2026 DUE TO AN OPEN LESION IN THE BIKINI AREA. PATIENT DENIED EXCESSIVE SUN EXPOSURE ON A TRIP TO (B)(6) OR ANY AGGRESSIVE MANIPULATION OF THE LESIONS. (B)(6) 2026 URGENT CARE NOTES INDICATE "FULL THICKNESS BURN OF GROIN DUE TO LASER HAIR REMOVAL, LIKELY DUE TO INAPPROPRIATE LASER SETTINGS. NO CURRENT INFECTION AND EXPECTED PROLONGED HEALING."

N

Patient 0

ROHRER AESTHETICS HAS MADE 4 ATTEMPTS TO PROVIDER TO OBTAIN PATIENT HEALING STATUS AND TO FURTHER EVALUATE TREATMENT PARAMETERS AND TECHNIQUES WITH NO RESPONSE. ROHRER AESTHETICS WILL TREND AND TRACK ADVERSE EVENTS OF A SIMILAR NATURE. ROHRER AESTHETICS WILL REOPEN CASE IF PROVIDER COMMUNICATES WITH ADDITIONAL INFORMATION.