MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-24 for RADIESSE INJECTABLE IMPLANT 8071M0K1 manufactured by Merz North America, Inc..
[187694694]
This case was assessed as reportable to the fda as the event, severe swelling, was deemed to meet the seriousness criteria of necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. The device history record for radiesse lot number 100123538 was reviewed. A lot search was conducted on the reported lot and no similar events were noted. No non-conformances were noted that would contribute to this event.
Patient Sequence No: 1, Text Type: N, H10
[187694695]
This spontaneous report was received from a us healthcare professional and concerns a female patient. She was injected with radiesse? Into the hands, on (b)(6) 2019. In (b)(6) 2019, since the treatment with radiesse? , the patient's left hand was swollen and had very unnatural appearance. The patient thought that too much product was injected. The outcome of the event was not reported. Follow-up information was received on 25-feb-2020: this case was upgraded to serious. The events pain with touch and mild erythema were added. The patients initials and date of birth were provided. She was (b)(6) years old. She was injected with a total of 2 ml of radiesse? (1 ml per hand). Batch number was reported as 100123538 (expiry date: 09/2022). The batch record review was received and the lot number for radiesse? Was confirmed as 100123538 (exp. 09/2022). A lot search in the global safety database was conducted. The patients medical history included breast cancer and thyroid cancer. The patients past medical history included a mastectomy and a lymphadenectomy to the left side. Concomitant medications were reported as none. On (b)(6) 2019, one day after the radiesse? Injection, the patient experienced swelling that was severe in nature. The patient also reported pain with touch and mild erythema. The patient was advised to keep the hand elevated above the heart, to perform compression, keep the hand moving to facilitate fluid removal, to perform icing and was prescribed over the counter pain medication. On (b)(6) 2019 the physician saw the patient and the events were fully resolved, reportedly within 2 - 3 weeks after the radiesse? Injection. No laboratory tests were performed. In the opinion of the reporter, treatment was necessary to prevent permanent damage, the events were not permanent and related to radiesse?.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013840437-2020-00031 |
| MDR Report Key | 9875545 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2019-12-05 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-09-24 |
| Date Added to Maude | 2020-03-24 |
| 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 | 2020-03-24 |
| Model Number | 8071M0K1 |
| Catalog Number | 8071M0K1 |
| Lot Number | 100123538 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-24 |