MAUDE MDR 9775273

MDR report key
9775273
Report number
MW5093434
Event key
0
Event type
3
Date of event
2020-02-27
Date received
2020-02-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CORALITE HEADACHE COOLING PADSPACK, HOT OR COLD DISPOSABLEUNKNOWNIMD Y
101---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-2801. H

Event Narratives#

D

Patient 1

HELLO MY NAME IS (B)(6) I USED THE COOLING HEADACHE/ MIGRAINE PADS A MONTH AND A HALF AGO AND MY SKIN GOT RED AND INFLAMED VERY BAD, I COULDN'T EVEN GO TO WORK BECAUSE MY FOREHEAD WAS JUST BURNING REALLY BAD AND SKIN STATED CRACKING AND PEELING WHEN I WENT TO THE DOCTOR HE THOUGHT IT WAS ROSACEA BECAUSE HE SAID THAT HE CAN'T FIND OUT WHAT ELSE CAN IT BE SO THEY GAVE ME ANTIBIOTICS THAT MADE IT WORSE. I BOUGHT THIS, A FACE WASH AND IT BALANCED IT A LITTLE BIT AND THEN YESTERDAY I USED IT AGAIN AND I WOKE UP IN THE MORNING WITH THE SAME RASH BUT NOW IT?S WORSE. I REALLY DON'T KNOW WHAT TO DO ANYMORE AND THAT HOW I FOUND OUT THAT IT WAS THE PADS. IT?S NOT OK THAT THERE?S NO SIDE EFFECTS ON THE PACKAGE. PLEASE HELP ME.