FDA.reportPublic FDA data

MAUDE MDR 24371655

MDR report key
24371655
Report number
3031944951-2026-00001
Event key
0
Event type
3
Date of event
2026-01-08
Date received
2026-02-17
Adverse event
1
Product problem
0
Patients in event
0
Reporter occupation
3
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
554496PHOENIXPOWERED LASER SURGICAL INSTRUMENTROHRER AESTHETICS, INC.GEXPHOENIXYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12026-02-170R

Event Narratives#

N

Patient 0

THE DEVICE IN QUESTION WAS TESTED AT THE USER FACILITY AND FOUND TO BE WITHIN SPECIFICATION. ROHRER'S CLINICAL TEAM REVIEWED BEST TREATMENT PRACTICES FOR THE DEVICE AND PATIENT WITH THE USER FACILITY. WOUND HEALED WITHOUT FURTHER CONCERN.

D

Patient 0

3 DAYS POST TREATMENT OF SKIN RESURFACING THE PATIENT REPORTED INFLAMMATION, ERYTHEMA, TISSUE EROSION, AND CRUSTING. PROVIDER INSTRUCTED PATIENT TO KEEP CLOTHING OFF SKIN, USE GENTLY CLEANSER, BYACYN SPRAY AND OCCLUSIVE. PATIENT REFERRED TO URGENT CARE BY PROVIDER FOR ASSESSMENT. PATIENT WAS PRESCRIBED BACITRACIN, KEFLEX AND BACTRIM. PATIENT WAS GIVEN WOUND CARE INSTRUCTIONS BY URGENT CARE PROVIDER. PROVIDER REPORTED A MARKED IMPROVEMENT NOTED WITHIN 48 HOURS.