MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,03,05 report with the FDA on 2011-06-10 for RADIESSE VOICE 8044M0 manufactured by Merz Aesthetics (formerly Bioform Medical).
[2059286]
This adverse event was reported in the journal: long-term results of caha for vocal fold augmentation, the laryngoscope 121: 313-319, (b)(6) 2011. Ninety pts (all over the age of (b)(6)) who had been treated with a total of 108 vocal fold injections with radiesse voice injections were evaluated. Three pts experienced adverse events, requiring surgical removal of the caha. Shortly after the radiesse voice injection, it was noted that the pt had an infraglottic collection of caha. This was presumed to have been migration of the product, as it was not recognized during the radiesse voice injection performed under microscopic visualization. Although not life-threatening, the caha required surgical removal.
Patient Sequence No: 1, Text Type: D, B5
[9010602]
No pt identifiers were provided. The vocal fold augmentation was performed by dr. (b)(6). The amount of radiesse voice, injection date, the date of surgical removal and the radiesse voice lot used were not provided in this article. Therefore, the device history records could not be reviewed. The pt outcome after the caha was removed, was not provided in the article.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2135225-2011-00055 |
| MDR Report Key | 2126485 |
| Report Source | 02,03,05 |
| Date Received | 2011-06-10 |
| Date of Report | 2011-05-24 |
| Date Mfgr Received | 2011-05-24 |
| Date Added to Maude | 2012-06-14 |
| 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, STE 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 |
| Generic Name | INJECTABLE IMPLANT |
| Product Code | KHJ |
| Date Received | 2011-06-10 |
| Catalog Number | 8044M0 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERZ AESTHETICS (FORMERLY BIOFORM MEDICAL) |
| Manufacturer Address | FRANKSVILLE WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-06-10 |