FDA.reportPublic FDA data

MAUDE MDR 3647175

MDR report key
3647175
Report number
MW5034702
Event key
0
Event type
3
Date of event
2014-02-04
Date received
2014-02-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
109
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RADIESSERADIESSEMERZ AESTHETICSMIX N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-02-2101. H

Event Narratives#

D

Patient 1

PT HAD VOCAL CORD INJECTION (RADIESSE) ON (B)(6) 2014 IN ENT OFFICE FOR VOCAL CORD PARALYSIS. DR INDICATED THERE WAS SOME BLEEDING BUT IT WAS CONTROLLED. SHE WAS RELEASED, DOING WELL AND AIDE STATES ON WAY HOME SHE BECAME SHORT OF BREATH IN CAR SO THEY DROVE TO ER. PT ARRIVED IN SEVERE RESPIRATORY DISTRESS BUT AWAKE. PT INTUBATED AND TRANSFERRED TO OPERATING ROOM. PT NOTED TO HAVE MODERATE POSTERIOR PHARYNGEAL SWELLING, EXHIBITED INSPIRATORY AND EXPIRATORY STRIDER, NO EXTERNAL NECK SWELLING, LABORED BREATHING. PARADOXICAL CHES AND MOVEMENT. BLOOD AND EDEMA BELOW VOCAL CORDS. DIAGNOSIS OR REASON FOR USE: VOCAL CORD PARALYSIS.