MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-07-01 for RADIESSE DERMAL FILLER UNK manufactured by Merz North America.
[15135426]
Patient was injected subcutaneously with a total of 0. 25 ml of radiesse into the left nasolabial fold for elastorrhexis on (b)(6) 2011. The needle used to inject radiesse was a 24g cannula. In (b)(6) 2015 the patient experienced formation of an aseptic nodule on the left cheek.
Patient Sequence No: 1, Text Type: D, B5
[15433795]
The nodule was removed per excision and sent for histological examination which showed crumbles of white subcutaneous material. Plastic reconstruction of the defect was performed. Systematic antibiotics were not prescribed to treat the event. The patient recovered. On (b)(6) 2015, the physician stated that the excision of the nodule was due to medical necessity. The nodule was causing pressure and the physician needed a histological examination to exclude a neoplasia. A scar remained in the nasolabial fold and is barely visible due to the location. The device history review could not be conducted as the lot number was not reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2135225-2015-00043 |
| MDR Report Key | 4895925 |
| Report Source | 01,05,07 |
| Date Received | 2015-07-01 |
| Date of Report | 2015-06-02 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-06-02 |
| Date Added to Maude | 2015-07-08 |
| 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 | T WATSON |
| 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 DERMAL FILLER |
| Generic Name | INJECTABLE IMPLANT |
| Product Code | PKY |
| Date Received | 2015-07-01 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERZ NORTH AMERICA |
| Manufacturer Address | FRANKSVILLE WI 53126 US 53126 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-01 |