MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-28 for RADIESSE 1.5 CC PER SYNIGE 8071M0K1 manufactured by Merz Aesthetic.
[35005593]
On (b)(6) 2015 patient received two syringes of radiesse 1. 5 cc each that was injected by cannula using aterila technique in combination with 0. 02 cc of lidocaine 1% with epinephrine 1:100,000 combined by busso technique. Procedure was completed without any issues or complaints from the patient. Five hours later patient called the office complaining of itching and rash in her face. She was promptly started prednisone 40mg and tapered dose over 9 days. On (b)(6) 2015 patient called the office that her rash was getting worse, now all over body and face, and face is now swollen. She was rushed to (b)(6) hospital in (b)(6) on (b)(6) 2015 for further evaluation of possible anaphylaxis. She was discharged without anaphylaxis to continue prednisone as well as diphenhydramine. As of (b)(6) 2015 patient was persistent swelling and itching, and is on a longterm tapering prednisone regimen until the gel portion of radiesse has dissolved. This can tax up to 3 months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058821 |
| MDR Report Key | 5340892 |
| Date Received | 2015-12-28 |
| Date of Report | 2015-01-10 |
| Date of Event | 2015-01-10 |
| Date Added to Maude | 2016-01-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RADIESSE 1.5 CC PER SYNIGE |
| Generic Name | RADIESSE INJECTABLE IMPLANT |
| Product Code | MIX |
| Date Received | 2015-12-28 |
| Catalog Number | 8071M0K1 |
| Lot Number | 100078330 |
| Device Expiration Date | 2017-10-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERZ AESTHETIC |
| Manufacturer Address | 6501 SIX FORKS ROAD RALEIGH NC 27615 US 27615 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-28 |