MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-17 for RADIESSE INJECTION NEEDLE * 8044MO manufactured by Bioform Medical Inc..
[16749312]
Physician was attempting to inject and medialize the true vocal cords. The injection needle malfunctioned/became clogged and was not useable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2603976 |
| MDR Report Key | 2603976 |
| Date Received | 2012-05-17 |
| Date of Report | 2012-05-17 |
| Date of Event | 2012-05-17 |
| Report Date | 2012-05-17 |
| Date Reported to FDA | 2012-05-17 |
| Date Added to Maude | 2012-06-07 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIESSE INJECTION NEEDLE |
| Generic Name | SYSTEM, VOCAL CORD MEDIALIZATION |
| Product Code | MIX |
| Date Received | 2012-05-17 |
| Model Number | * |
| Catalog Number | 8044MO |
| Lot Number | LOG247665 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOFORM MEDICAL INC. |
| Manufacturer Address | 4133 COURTNEY ROAD SUITE 10 FRANKSVILLE WI 53126 US 53126 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-17 |