MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-03-09 for RADIESSE INJECTABLE IMPLANT 8071M0K1 manufactured by Merz North America, Inc..
[102017267]
This case was assessed as reportable to the fda as the event was deemed to meet serious injury criteria of necessitating 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 dermal filler lot 100089473 was reviewed. No non-conformances were noted that would have contributed to this event. A lot search was conducted on the reported lot and no similar events were noted.
Patient Sequence No: 1, Text Type: N, H10
[102017268]
This spontaneous report was received from a (b)(6)-year-old female patient, a nurse practitioner, who was injected with 1cc of radiesse about one month ago for hands indication. Concomitant medication reported as synthroid (levothyroxine). Medical history positive for sulfa allergy. Right after injection (also reported as (b)(6) 2018), the patient experienced swelling, pinkness and pain to the right hand. It was so painful, she could not sleep that night. The following day, she developed the same symptoms in her left hand. An orthopedic surgeon friend thought she had cellulitis and started her on an unspecified broad spectrum antibiotic. She did not otherwise see a physician. Reporter clarified the antibiotic was not started as a prophylactic measure but as treatment. The patient experienced improvement in her symptoms "right after" starting antibiotic. The symptoms were resolved after three weeks. Lot number reported as 100089473.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135225-2018-00010 |
| MDR Report Key | 7327336 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-03-09 |
| Date of Report | 2018-03-09 |
| Date Mfgr Received | 2018-03-07 |
| Device Manufacturer Date | 2016-03-16 |
| Date Added to Maude | 2018-03-09 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SCOTT SYKES, MD |
| Manufacturer Street | 6501 SIX FORKS ROAD |
| Manufacturer City | RALEIGH NC 27615 |
| Manufacturer Country | US |
| Manufacturer Postal | 27615 |
| Manufacturer Phone | 9195828000 |
| Manufacturer G1 | MERZ NORTH AMERICA |
| Manufacturer Street | 4133 COURTNEY STREET SUITE 10 |
| Manufacturer City | FRANKSVILLE WI 53126 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53126 |
| 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 IN THE HANDS |
| Product Code | PKY |
| Date Received | 2018-03-09 |
| Model Number | 8071M0K1 |
| Catalog Number | 8071M0K1 |
| Lot Number | 100089473 |
| Device Expiration Date | 2019-03-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 53126 US 53126 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-09 |