FDA.reportPublic FDA data

MAUDE MDR 9181135

MDR report key
9181135
Report number
3011137372-2019-00341
Event key
0
Event type
3
Date of event
2019-08-08
Date received
2019-10-11
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
KATHARINE TARPLEY
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
1LMA UNIQUE (SILICONE CUFF) CPV SIZE 5LMA UNIQUETELEFLEX MEDICALCAE105200-000050UNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-10-1101. R

Event Narratives#

N

Patient 1

(B)(4).

D

Patient 1

CUSTOMER REPORTED THE DEVICE WOULD NOT SEAT WELL UPON THREE ATTEMPTS BY EXPERIENCED PROVIDERS FOR A GENERAL ANESTHESIA CASE. PATIENT HAD TO BE INTUBATED AND WAS GIVEN A MUSCLE RELAXANT. CUSTOMER REPORTED THAT UPON EMERGENCE THE PATIENT COUGHED AGAINST THE ETT AND DESATURATED INTO THE 80'S. THE ANESTHESIOLOGIST WAS CALLED TO THE ROOM AND REINTRODUCED ANESTHESIA TO ATTEMPT A SMOOTHER WAKE UP. THE PATIENT AGAIN HAD DESATURATION INTO THE 80'S. PATIENT WAS EVENTUALLY WOKEN UP WITH NO LONG TERM HARM, BUT THE DIFFICULTY WITH EMERGENCE ADDED 15 MINUTES TO THE OR TIME AT THE END OF THE CASE.