MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-06-14 for RADIESSE INJECTABLE IMPLANT 8069M4K1 manufactured by Merz North America, Inc..
[77583654]
This case was assessed as reportable to the fda as the event, cellulitis, 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 injectable implant lot number 100082548 was reviewed. No nonconformances were discovered that would have contributed to this event. A lot search was conducted on the reported lot and no similar complaints were noted.
Patient Sequence No: 1, Text Type: N, H10
[77583655]
This spontaneous report was received from a canadian nurse and concerns a (b)(6) female patient (herself) who was injected with a total of 0. 8 ml of radiesse into right hand for hand rejuvenation on (b)(6) 2017. Batch number was reported as 100082548 (expiry date in may-2017). Radiesse was mixed with 0. 5 ml of 1% xylocaine. The patient had previous toxin and filler treatments for the last 12 years without any reaction before. This was the patient's first time receiving radiesse as well as her first time receiving treatment in her hand. The patient's medical history included hypothyroidism and fungal/bacterial infection in her right thumb in the last 6 months. The patient's concomitant medications included marvelon and synthroid. The patient's past medications included antibiotics. On (b)(6) 2017, 12 hours after radiesse injection, the patient experienced swelling, redness and heat in the right hand. By (b)(6) 2017, the patient's hand was visibly swollen and the physician at her clinic recommended her to go to hospital emergency department. The patient went to the hospital on (b)(6) 2017, where she received oral antibiotics. The emergency physician examined the patient's hand and noted that the infection spread to the patient's elbow (redness, swelling and heat up to the elbow) and that the patient's right axillary gland was swollen. The patient was prescribed 1000 mg of keflex every 6 hours for the first 48 hours, followed by 1000 mg keflex twice a day until medication was finished. On (b)(6) 2017, the patient reported that she was stable, but she did not notice any improvement yet, therefore the outcome of the event was considered as not resolved. In the opinion of the reporter, the event was of severe intensity, not permanent, nor life-threatening and related to radiesse. Follow-up information was received on 24-may-2017: the event was changed from infection to cellulitis. The needle used for injection was reported as 25g, 1. 5 inch (100093236) cannula. Previous information already included that the physician believed that the bacteria from the thumb infection were still present in a dormant form and possibly reactivated by the radiesse injection. On (b)(6) 2017, the patient went for her follow-up appointment at the hospital, and the physician was pleased with her progress. The patient was not treated with iv antibiotics by her physician. The more accurate diagnosis was cellulitis that could have spread to a more serious condition. The physician commented that the timely intervention provided on (b)(6) 2017, prevented the worsening of the patient's condition, and added that if they did not treat her on (b)(6) 2017, by the next day there was a possibility the patient had to be hospitalized for 2 days due to the spread of the infection. As per reporter, the patient went to the hospital for less than 24 hours. The patient had leftover medication that she had to finish completely. The patient reported she felt much better and informed there was slight redness remained on the hand (1 on a scale of 4). Due to the provided information, the outcome for the event was considered as resolving. Follow-up information was received on 07-jun-2017: on (b)(6) 2017, all the redness resolved. It was confirmed that the patient completely recovered and that she was satisfied with her treatment. The outcome of the event was therefore changed from resolving to resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135225-2017-00012 |
| MDR Report Key | 6641558 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-06-14 |
| Date of Report | 2017-06-14 |
| Date of Event | 2017-05-17 |
| Date Mfgr Received | 2017-05-18 |
| Device Manufacturer Date | 2015-05-28 |
| Date Added to Maude | 2017-06-14 |
| 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 | 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, INC. |
| Manufacturer Street | 4133 COURTNEY ST., 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 | 2017-06-14 |
| Catalog Number | 8069M4K1 |
| Lot Number | 100082548 |
| Device Expiration Date | 2017-05-31 |
| Operator | NURSE |
| 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 ST., SUITE 10 FRANKSVILLE WI 53126 US 53126 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-06-14 |