FDA.reportPublic FDA data

MAUDE MDR 5681883

MDR report key
5681883
Report number
3004365956-2016-00223
Event key
0
Event type
3
Date of event
2016-03-19
Date received
2016-05-26
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#

Contact
MARGIE BURTON, RN
Address
3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US
Phone
919-919-9194
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HUDSON BITE-GARD MOLAR BITE BLOCKENDOSCOPIC BITE GARD W/ ACCES.TELEFLEX MEDICALMNK114074A1600827R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-05-260

Event Narratives#

N

Patient 1

(B)(4). A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. NO PHOTO AVAILABLE. THE DEVICE HISTORY RECORD OF BATCH NUMBER 74A1600827 THAT BELONG TO CATALOG NUMBER 1140 HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY BE RELATED TO THIS COMPLAINT. NO NON CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED & INSPECTED ACCORDING TO OUR SPECIFICATIONS. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE TO THE LACK OF A SAMPLE. AN ATTEMPT TO DUPLICATE THE FAILURE MODE WAS MADE BUT AT THE TIME THERE IS NO INVENTORY OF THE INVOLVED PRODUCT CODE AVAILABLE AT THE FACILITY AND IT IS NOT BEING MANUFACTURED AT THE TIME. IF THE DEVICE SAMPLE BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED WITH THE EVALUATION RESULTS.

D

Patient 1

THE CUSTOMER ALLEGES THAT A PATIENT HAD A SEIZURE AND BIT THOUGH THE BITE BLOCK. THE PATIENT BROKE THE BITE BLOCK, BUT THE INTUBATION TUBE BLOCKED IT FROM GOING ANY FURTHER. FORCEPS WERE USED TO REMOVE THE BITE BLOCK. THE PATIENT'S CONDITION IS REPORTED AS FINE.