FDA.reportPublic FDA data

MAUDE MDR 8436732

MDR report key
8436732
Report number
1319130-2019-00001
Event key
0
Event type
3
Date of event
2019-02-26
Date received
2019-03-20
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LAUREN JOHNSON
Address
31 WATER STREET #1 CUBA NY 14727 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HU-FRIEDLY SPORECHECK IN-OFFICE SPORE TESTBIOLOGICAL INDICATORCROSSTEX SPS MEDICALFRCIMS-1373IMS-13736743R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-2001. O

Event Narratives#

N

Patient 1

THE FACILITY REPORTED A DENTAL ASSISTANT WAS USING A BIOLOGICAL INDICATOR (BI) WHEN THE VIAL BURST, RESULTING IN GLASS SHATTERING NEAR THE DENTAL ASSISTANT'S FACE. THERE IS POTENTIAL HER EYE WAS EXPOSED TO THE CONTENTS OF THE VIAL AND GLASS. AFTER THE BI BURST, THE DENTAL ASSISTANT FLUSHED HER EYES AND SOUGHT MEDICAL ATTENTION TO ENSURE NO GLASS PARTICLES WERE IN HER EYE. SHE IS REPORTED TO BE DOING FINE AND NO ADDITIONAL EYE IRRITATION HAS BEEN REPORTED. REGULATORY AFFAIRS MADE SEVERAL ATTEMPTS TO CONTACT THE FACILITY AND WAS UNABLE TO CONFIRM THE DETAILS OF THE INCIDENT OR IF THE USER WAS WEARING PROPER PROTECTIVE EQUIPMENT DURING THE EVENT. THE INSTRUCTIONS FOR USE INSTRUCT WAITING 10 MINUTES AFTER THE VIAL IS REMOVED FROM THE AUTOCLAVE BEFORE ACTIVATION TO ENSURE THE VIAL HAS COOLED DOWN. IT IS UNKNOWN IF THE USER FOLLOWED THIS INSTRUCTION. THE FACILITY DID NOT SEND PRODUCT BACK FOR INVESTIGATION. CROSSTEX SPS MEDICAL QUALITY ASSURANCE TEAM TESTED 30 VIALS FROM THE SAME LOT NUMBER AND COULD NOT REPRODUCE THE INCIDENT REPORTED BY THE FACILITY. THIS WILL CONTINUE TO BE MONITORED IN THE CROSSTEX SPS MEDICAL COMPLAINT HANDLING SYSTEM.

D

Patient 1

THE FACILITY REPORTED A DENTAL ASSISTANT WAS USING A BIOLOGICAL INDICATOR (BI) WHEN THE VIAL BURST, RESULTING IN GLASS SHATTERING NEAR THE DENTAL ASSISTANT'S FACE. THERE IS POTENTIAL HER EYE WAS EXPOSED TO THE CONTENTS OF THE VIAL AND GLASS.