FDA.reportPublic FDA data

MAUDE MDR 2189666

MDR report key
2189666
Report number
8032044-2011-00001
Event key
0
Event type
3
Date of event
2011-06-12
Date received
2011-07-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
FERENC DAHNER, MGR
Address
PO BOX 183 HORBY SE-24 SW
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PROVOX LARYTUBETUBE, LARYNGECTOMYATOS MEDICAL ABESE9/55 WITH RING76270508093Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-07-1501. O

Event Narratives#

D

Patient 1

THE PT STATED THAT HER TUBE WAS YELLOW IN APPEARANCE AND SHE DID CLEAN IT WITH SOMEONE ELSE'S BRUSH AND PEROXIDE. THE BACK END OF THE TUBE BROKE OFF AND SHE STARTED COUGHING, SHE HAD SHORTNESS OF BREATH AND PAIN IN HER SIDE SO SHE WENT TO THE EMERGENCY ROOM TO GET AN X-RAY AND A MRI, BOTH WAS NEGATIVE. THE PT HAD PROBABLY COUGHED IT OUT.

N

Patient 1

WHEN EXAMINING THE LARYTUBE IT WAS DEFINITELY WARNED OUT AND A BIG PIECE WAS MISSING IN THE TOP OF THE TUBE. THE PRODUCT HAS BEEN EXPOSED TO SEVERE DAMAGE. THERE ARE DEEP "CHANNELS" INSIDE THE TUBE. IT IS UNCLEAR WHAT KIND OF BRUSH THAT HAVE BEEN USED AS WELL AS WHAT KIND OF PEROXIDE. ACCORDING TO THE IFU THE LARYTUBE SHOULD BE CLEANED WITH SOFT SPONGE OF SOFT-BRISTLED BRUSH IN HOT WATER-SOAP SOLUTION AND THE EXAMINED TUBE HAS DEFINITELY NOT BEEN CLEANED ACCORDING TO IFU AND THAT HAS CAUSED THE DAMAGE TO THE TUBE. (B)(4).