FDA.reportPublic FDA data

MAUDE MDR 5563024

MDR report key
5563024
Report number
MW5061556
Event key
0
Event type
3
Date of event
2016-03-21
Date received
2016-04-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SAGE ORAL HYGIENE PRODUCTSSAGE SUCTION/CLEANING SWAB/TOOTHETTESAGE PRODUCTSKXF6512UNK* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-04-0501. O

Event Narratives#

D

Patient 1

WHILE ORAL CARE WAS BEING RENDERED TO THE PATIENT USING A TOOTHETTE SUCTION SWAB, THE PATIENT BIT DOWN ON THE PLASTIC PART OF THE TOOTHETTE AND BROKE IT IN HALF, RETAINING THAT PIECE IN HIS MOUTH. NUMEROUS, VARIOUS ATTEMPTS TO REMOVE THE (3.5 CM) DISTAL END OF THE TOOTHETTE WERE UNSUCCESSFUL. THE PATIENT HAD INCREASED DYSPNEA AND A MOIST COUGH, BUT NO STRIDOR. THE MD EXAMINED THE PATIENT AND VIA DIRECT LARYNGOSCOPY VISUALIZED THE SPONGE STICK PIECE IN THE LOWER HYPOPHARYNX OVERLYING THE VOCAL CORDS, PARTIALLY OBSTRUCTING THE AIRWAY. THE PIECE WAS REMOVED INTACT USING MCGILL FORCEPS AND THE OROPHARYNX WAS SUCTIONED THOROUGHLY. CXR POST-EVENT CONFIRMED REMOVAL OF THE FOREIGN BODY.