MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,03 report with the FDA on 2010-04-30 for RADIESSE VOICE 8044M0 manufactured by Bioform Medical, Inc..
[16736928]
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.
Patient Sequence No: 1, Text Type: D, B5
[17016220]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2135225-2010-00017 |
| MDR Report Key | 1673983 |
| Report Source | 02,03 |
| Date Received | 2010-04-30 |
| Date of Report | 2010-04-22 |
| Date Mfgr Received | 2010-04-22 |
| Date Added to Maude | 2010-05-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BECKY KRON |
| Manufacturer Street | 4133 COURTNEY ROAD SUITE 10 |
| Manufacturer City | FRANKSVILLE WI 53126 |
| Manufacturer Country | US |
| Manufacturer Postal | 53126 |
| Manufacturer Phone | 2628353300 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIESSE VOICE |
| Generic Name | INJECTABLE IMPLANT |
| Product Code | MIX |
| Date Received | 2010-04-30 |
| Catalog Number | 8044M0 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOFORM MEDICAL, INC. |
| Manufacturer Address | FRANKSVILLE WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2010-04-30 |