MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-25 for RADIESSE INJECTABLE IMPLANT manufactured by Merz North America, Inc..
[186134130]
This case was assessed as reportable to the fda as the event, accidental cannulation of an artery (vessel perforation), was assessed as necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. The device history record could not be reviewed as the lot number was not reported.
Patient Sequence No: 1, Text Type: N, H10
[186134131]
This spontaneous report was received from a us physician and concerns a patient. The patient was injected with radiesse?. During the radiesse? Injection, the patient experienced an accidental cannulation of an artery. The physician requested a written emergency protocol. The outcome of the event was not reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013840437-2020-00038 |
| MDR Report Key | 9877982 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | PRODUCT SAFETY |
| Manufacturer Street | 6501 SIX FORKS ROAD |
| Manufacturer City | RALEIGH, NC |
| Manufacturer Country | US |
| Manufacturer Phone | 5828000 |
| Manufacturer G1 | MERZ NORTH AMERICA, INC. |
| Manufacturer Street | 4133 COURTNEY STREET SUITE 10 |
| Manufacturer City | FRANKSVILLE, WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIESSE INJECTABLE IMPLANT |
| Generic Name | IMPLANT, DERMAL, FOR AESTHETIC USE |
| Product Code | LMH |
| Date Received | 2020-03-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERZ NORTH AMERICA, INC. |
| Manufacturer Address | 4133 COURTNEY STREET SUITE 10 FRANKSVILLE, WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-25 |