MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2012-06-20 for RADIESSE VOICE GEL 8602M0 manufactured by Merz Aesthetics, Inc..
[2765869]
This complaint was e-mailed to merz aesthetics, inc. By patient's daughter. She wrote that her mother was injected with radiesse voice gel into left vocal fold on (b)(6) 2012, for a paralyzed left vocal fold following left lung removal. Three days later, she felt weak and had a need to cough. Two weeks later, she has a fever, cough, and uncontrolled tachycardia/a-fib, unable to cardiovert. A ct scan revealed a "nodule" in her remaining lung of 6mm which was not there two months ago when they found the left lung cancer. On (b)(6) 2012, patient's daughter provided additional information. Her mother is now hospitalized as of (b)(6) 2012, for uncontrolled tachycardia/atrial fibrillation. She stated the doctors were supposed to "cardiovert with paddles" but decided to wait and attempt to control events with medications. The patient is taking cardarone and heparin. The patient also has fever and is coughing. The nodule in the right lung lobe will be examined further once the patient is stable. At this time, it is unknown if the nodule is cancer or radiesse voice gel. Per patient's daughter, dr. (b)(6) was the radiesse voice gel injecting physician. On (b)(6) 2012, dr. (b)(6) stated that he does not agree that radiesse voice gell caused any of the patient's adverse event. No other information was provided. On (b)(6) 2012, patient's daughter stated her "mother-in-law" is out of a-fib, is on medication, name not provided; she is still in the hospital, now has "stomach troubles;" the heart is "ok. " as of (b)(4) 2012, despite several attempts to obtain additional information, none was received.
Patient Sequence No: 1, Text Type: D, B5
[10060929]
The device history records were not reviewed as the lot number was not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2135225-2012-00058 |
| MDR Report Key | 2634178 |
| Report Source | 00,05 |
| Date Received | 2012-06-20 |
| Date of Report | 2012-06-19 |
| Date of Event | 2012-05-24 |
| Date Mfgr Received | 2012-05-24 |
| Date Added to Maude | 2012-08-07 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JELENA SOCAVA |
| Manufacturer Street | 4133 COURTNEY RD. SUITE 10 |
| Manufacturer City | FRANKSVILLE WI 53126 |
| Manufacturer Country | US |
| Manufacturer Postal | 53126 |
| Manufacturer Phone | 2628353300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIESSE VOICE GEL |
| Generic Name | RADIESSE INJECTABLE IMPLANT |
| Product Code | MIX |
| Date Received | 2012-06-20 |
| Catalog Number | 8602M0 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERZ AESTHETICS, INC. |
| Manufacturer Address | FRANKSVILLE WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-06-20 |