FDA.reportPublic FDA data

MAUDE MDR 4860157

MDR report key
4860157
Report number
2135225-2015-00041
Event key
0
Event type
3
Date of event
2015-05-13
Date received
2015-06-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
T WATSON
Address
4133 COURTNEY ROAD, #10 FRANKSVILLE WI 53126 US
Phone
262-262-2628
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PROLARYN PLUSMERZ NORTH AMERICAKHJR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-06-1901. H; 2. R

Event Narratives#

N

Patient 1

IN THE EMERGENCY ROOM PT HAD A CT SCAN WHICH SHOWED A NODULAR MASS IN THE SUPRAGLOTTIC AREA, SUGGESTING POSSIBLE CALCIUM DEPOSIT. THERE WAS EDEMA AROUND THE MASS. THIS WAS ABOVE THE INJECTION SITE. THE PT HAD NO AIRWAY PROBLEM, BUT HIS MAIN TROUBLE WAS THAT HE COULDN'T "GET ANYTHING DOWN." BECAUSE HE COULDN'T GET ANYTHING DOWN, HE WAS ADMITTED TO THE HOSP AND PUT ON IV STEROIDS AND ANTIBIOTICS. BY (B)(6) 2015, HE WAS SWALLOWING ENOUGH SO THAT HE COULD GO HOME. PHYSICIAN CALLED PT ON (B)(6) 2015 AND HE WAS DOING OKAY. THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED AS THE LOT NUMBER WAS NOT REPORTED.

D

Patient 1

PHYSICIAN INJECTED PT WITH PROLARYN PLUS FOR LEFT VOCAL CORD PARALYSIS ON (B)(6) 2015. HE INJECTED 0.7 CC TO THE LEFT VOCAL CORD AND THE REMAINDER OF THE SYRINGE TO THE RIGHT VOCAL CORD. TWO DAYS LATER PT WENT TO THE EMERGENCY ROOM COMPLAINING OF DIFFICULTY SWALLOWING, THROAT PAIN, AND A LOW GRADE FEVER.