FDA.reportPublic FDA data

MAUDE MDR 8391055

MDR report key
8391055
Report number
2320643-2019-00001
Event key
0
Event type
3
Date received
2019-03-05
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
PO BOX 13398 RESEARCH TRIANGLE PARK NC 27709 US
Phone
888-888-8888
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BREATHE RIGHT NASAL STRIPSNASAL STRIPSWEBTEC DIV OF SCARPA HEALTHCARELWFUNKNOWNR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-0501. O

Event Narratives#

N

Patient 1

MDR: 2320643-2019-00001 IS ASSOCIATED WITH ARGUS CASE (B)(4), BREATHE RIGHT NASAL STRIPS.

D

Patient 1

THE DOCTOR SAID HE MAY HAVE SKIN CANCER (SKIN CANCER). HE DID THAT AND HE WOUND UP WITH A SORE ON HIS NOSE (NASAL SORENESS). IT HAS TORN THE SKIN OFF HIS NOSE (APPLICATION SITE SKIN TEAR). HE WOUND UP WITH A SORE ON HIS NOSE (APPLICATION SITE INJURY). CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF SKIN CANCER IN A (B)(6) YEAR-OLD MALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS NASAL STRIP (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED BREATHE RIGHT NASAL STRIPS. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BREATHE RIGHT NASAL STRIPS, THE PATIENT EXPERIENCED SKIN CANCER (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), NASAL SORENESS, APPLICATION SITE SKIN TEAR AND APPLICATION SITE INJURY. THE ACTION TAKEN WITH BREATHE RIGHT NASAL STRIPS WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE SKIN CANCER, NASAL SORENESS, APPLICATION SITE SKIN TEAR AND APPLICATION SITE INJURY WERE UNKNOWN. THE REPORTER CONSIDERED THE SKIN CANCER TO BE POSSIBLY RELATED TO BREATHE RIGHT NASAL STRIPS. THE REPORTER CONSIDERED THE NASAL SORENESS, APPLICATION SITE SKIN TEAR AND APPLICATION SITE INJURY TO BE RELATED TO BREATHE RIGHT NASAL STRIPS. ADDITIONAL INFORMATION ADVERSE EVENT INFORMATION WAS RECEIVED ON 25 FEBRUARY 2019, VIA PHONE CALL. CONSUMER REPORTED THAT, "MY BROTHER TOLD ME NOT JUST TO RIP OFF THE STRIPS HE DID THAT AND HE WOUND UP WITH A SORE ON HIS NOSE. HE IS HAVING DIFFICULTY REMOVING THE SORE, AND HE VISITED A DOCTOR. IT HAS TORN THE SKIN OFF HIS NOSE. THE DOCTOR SAID HE MAY HAVE SKIN CANCER. THIS CASE WAS LINKED WITH (B)(4)."