MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-01-02 for RADIESSE VOICE INJECTABLE IMPLANT 1011675 manufactured by Bioform Medical.
[1020689]
Pt rec'd radiesse voice injectable implant by surgeon and almost immediately noted to have drop in bp. No wheezes or hives but bp treated with vasopressors and epi as well as solumedrol, benadryl, zantac. The pt had nka noted but did receive cefazolin 1 gm ivp 5 min prior to the voice injectable implant injection. Dose or amount: 2 syringes (2ml). Frequency: once. Route: 039. Date of use: 2008. Diagnosis or reason for use: glottic incompetence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5009513 |
| MDR Report Key | 1277372 |
| Date Received | 2009-01-02 |
| Date of Report | 2008-12-16 |
| Date of Event | 2008-12-16 |
| Date Added to Maude | 2009-01-16 |
| 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 |
| 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 VOICE INJECTABLE IMPLANT |
| Generic Name | RADIESSE VOICE INJECTABLE IMPLANT |
| Product Code | MIX |
| Date Received | 2009-01-02 |
| Model Number | 1011675 |
| ID Number | 8044MO |
| Device Expiration Date | 2010-10-01 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOFORM MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2009-01-02 |