FDA.reportPublic FDA data

MAUDE MDR 9670475

MDR report key
9670475
Report number
9670475
Event key
0
Event type
3
Date of event
2020-01-31
Date received
2020-02-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1STERILE TONGUE DEPRESSOR, 6"DEPRESSOR, TONGUE, NON-SURGICALMEDLINE INDUSTRIES, INC.FMAMDS202075* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-0501. H; 2. O; 3. R

Event Narratives#

D

Patient 1

PATIENT WAS UNDERGOING A GYN SURGICAL PROCEDURE. THE INTUBATION WAS DIFFICULT. THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) USED A TONGUE DEPRESSOR TO EXPOSE THE BASE OF THE TONGUE AND THE DISTAL TIP OF THE TONGUE DEPRESSOR BROKE OFF AND WAS LOST IN THE PATIENT'S AERODIGESTIVE TRACT. AN ENT WAS CONSULTED FOR REMOVAL WHILE THE PATIENT WAS IN THE OPERATION ROOM. THE FOREIGN BODY WAS REMOVED FROM THE RIGHT NASOPHARYNX. THE PATIENT WAS ADMITTED FOR OBSERVATION FOLLOWING THE REMOVAL. THE PATIENT UNDERWENT FURTHER STUDIES AND THE PATIENT WAS DIAGNOSED WITH A HYPOPHARYNGEAL/PHARYNGEAL PERFORATION, CONFIRMED FREE AIR IN THE NECK, SIGNIFICANT DYSPHAGIA AND ODYNOPHAGIA, AND CONTRAST ASPIRATION.