FDA.reportPublic FDA data

MAUDE MDR 6136083

MDR report key
6136083
Report number
2320643-2016-00012
Event key
0
Event type
3
Date received
2016-11-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
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 A DIVISION OF SCARPA HEALTHCARELWFUNKR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-11-3001. L; 2. O

Event Narratives#

N

Patient 1

THIS REPORT IS ASSOCIATED WITH ARGUS CASE (B)(4), BREATHE RIGHT NASAL STRIPS.

D

Patient 1

SHE ALSO STATED SHE HAD A STROKE. SHE ALSO STATED SHE HAD A STROKE AND CAN NOT SLEEP. CONSUMER STATED SHE NEEDS A SLEEP MASK, HAVING TROUBLE WITH HER EYES. I'M NEEDING A SLEEP MASK. I HAVE TROUBLE WITH MY EYES. ANY KIND OF LIGHT BOTHERS ME/ SENSITIVE TO LIGHT . CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA INTERACTIVE DIGITAL MEDIA AND DESCRIBED THE OCCURRENCE OF STROKE IN A FEMALE PATIENT WHO RECEIVED BREATHE RIGHT NASAL STRIPS NASAL STRIP (BATCH NUMBER UNK, EXPIRY DATE UNKNOWN) FOR DRUG USE 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 STROKE (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT, LIFE THREATENING AND OTHER: GSK MEDICALLY SIGNIFICANT), DIFFICULTY SLEEPING, EYE DISORDER AND PHOTOPHOBIA. THE ACTION TAKEN WITH BREATHE RIGHT NASAL STRIPS WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE STROKE, DIFFICULTY SLEEPING, EYE DISORDER AND PHOTOPHOBIA WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE STROKE, DIFFICULTY SLEEPING, EYE DISORDER AND PHOTOPHOBIA TO BE RELATED TO BREATHE RIGHT NASAL STRIPS. ADDITIONAL DETAILS, CONSUMER REPORTED THAT HER DAD USED THEM HE ALSO DIED FROM CANCER SO THANKS FOR HELPING HIM BREATH EASY. SHE STARTED USING THEM AFTER THAT JUST TO TRY IT IN BAD COLD WORKED GREAT NOW SHE WAS NEEDING A SLEEP MASK. SHE HAD STROKE AND HAD TROUBLE EYES COULD NOT SLEEP ANY KIND OF LIGHT BOTHERED HER.