FDA.reportPublic FDA data

MAUDE MDR 6689091

MDR report key
6689091
Report number
3004699328-2017-00009
Event key
0
Event type
3
Date received
2017-07-06
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
1COREGA ADHESIVE STRIPSDENTURE ADHESIVEKYOWA, LTD.KOLR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-0601. O

Event Narratives#

N

Patient 1

THIS REPORT IS ASSOCIATED WITH (B)(4), COREGA ADHESIVE STRIPS. COREGA ADHESIVE STRIPS ARE MARKETED IN THE US AS SUPER POLIGRIP COMFORT SEAL ADHESIVE STRIP.

D

Patient 1

PROFUSE BLEEDING [HEMORRHAGE]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A DENTIST VIA SALES REP AND DESCRIBED THE OCCURRENCE OF BLEEDING IN A (B)(6) FEMALE PATIENT WHO RECEIVED POLYETHYLENE OXIDE, SODIUM CARBOXYMETHYLCELLULOSE (COREGA ADHESIVE STRIPS) STRIP FOR PRODUCT USED FOR UNKNOWN INDICATION. ON AN UNKNOWN DATE, THE PATIENT STARTED COREGA ADHESIVE STRIPS. ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING COREGA ADHESIVE STRIPS, THE PATIENT EXPERIENCED BLEEDING (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE OUTCOME OF THE BLEEDING WAS UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE BLEEDING TO BE RELATED TO COREGA ADHESIVE STRIPS. ADDITIONAL DETAILS, INITIAL ADVERSE EVENT REPORT WAS RECEIVED ON 26 JUN 2017 THROUGH SALES REPRESENTATIVE. THE REPORTER COMMENTED THAT A (B)(6) FEMALE PATIENT CONSUMED ANTICOAGULANTS, SHE RETIRED HER DENTAL PROSTHESIS PLACED WITH COREGA ADHESIVE AND THE PATIENT HAD A PROFUSE BLEEDING. THE ACTION TAKEN OF COREGA ADHESIVE STRIPS WAS UNKNOWN. THIS REPORT WAS BEING RESUBMITTED TO CAPTURE CORRECTIONS. THE INFORMATION WAS RECEIVED ON 01 JUL 2017 AND WAS AS FOLLOWS: THE DEVICE TYPE WAS CAPTURED WRONG AS DERMATOLOGICAL DEVICE WHICH WAS CHANGED TO DENTURE ADHESIVE. THIS REPORT WAS BEING RESUBMITTED TO CAPTURE CORRECTIONS. THE INFORMATION WAS RECEIVED ON 26 JUN 2017 AND THE INFORMATION AS FOLLOWS: THE PREVIOUS ERROR CORRECTION DATE 01 JUL 2017 (WRONG DATE REPORTED) WAS UPDATED TO 26 JUN 2017 (CORRECTED DATE).