MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-21 for RADIESSE manufactured by Merz Aesthetics.
[4183484]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034702 |
| MDR Report Key | 3647175 |
| Date Received | 2014-02-21 |
| Date of Report | 2014-02-06 |
| Date of Event | 2014-02-04 |
| Date Added to Maude | 2014-02-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIESSE |
| Generic Name | RADIESSE |
| Product Code | MIX |
| Date Received | 2014-02-21 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERZ AESTHETICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-02-21 |