FDA.reportPublic FDA data

MAUDE MDR 1673983

MDR report key
1673983
Report number
2135225-2010-00017
Event key
0
Event type
3
Date received
2010-04-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
BECKY KRON
Address
4133 COURTNEY ROAD SUITE 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
1RADIESSE VOICEINJECTABLE IMPLANTBIOFORM MEDICAL, INC.MIX8044M0UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-04-3001. H

Event Narratives#

D

Patient 1

A PATIENT INJECTED WITH RADIESSE VOICE DEVELOPED DYSPNEA 12 HOURS AFTER THE VOCAL FOLD INJECTION. EXAMINATION OF THE AIRWAY WITH FIBER-OPTICS INDICATED THE AIRWAY WAS OPEN, BUT DUE TO CONCERN FOR OBSTRUCTION, THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS TREATED WITH DEXAMETHASONE (STEROID), NEBULIZED IPRATROPIUM BROMIDE (BRONCHODILATOR) AND RACEMIC EPINEPHRINE (BRONCHODILATOR). THE PATIENT WAS RELEASED AFTER RECOVERY WITHOUT FURTHER INTERVENTION. LARYNGOSCOPE (PROFESSIONAL JOURNAL). VOLUME 120 (703-706). APRIL 2010. AUTHORS: YAMILET TIRADO, MD; JAN S. LEWIN, PHD; KATHERINE A. HUTCHESON, MS; MICHAEL E. KUPFERMAN, MD.

N

Patient 1

THIS PATIENT SHOWED MARKED IMPROVEMENT IN VOCAL PRODUCTION DURING A ROUTINE FOLLOW-UP. RADIESSE VOICE IFU WARNINGS SECTION INDICATES: AIRWAY OBSTRUCTION FOLLOWING VOCAL FOLD INJECTION CAN OCCUR IMMEDIATELY OR AT ANYTIME UP TO SEVEN DAYS FOLLOWING (RADIESSE VOCAL) INJECTION. THIS AE WAS FOUND IN THE PROFESSIONAL JOURNAL OF LARYNGOSCOPE: APRIL 2010 (OFFICE-BASED INJECTION LARYNGOPLASTY IN THE IRRADIATED LARYNX). THE DATA FOR THIS ARTICLE WAS FROM A STUDY AT THE (B) (6), COMPOSED OF 100 PATIENTS TREATED FOR VOCAL FOLD PARALYSIS FROM JANUARY 2007 TO FEBRUARY 2009. FROM THIS STUDY, 11 PATIENTS WERE IDENTIFIED WITH HAVING PRIOR XRT TO THE NECK AND WERE TREATED WITH EITHER CYMETRA OR RADIESSE.