MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,literature report with the FDA on 2020-03-25 for RADIESSE INJECTABLE IMPLANT manufactured by Merz North America, Inc..
[186601901]
This case was assessed as reportable to the fda as the event, giant lumps/ giant ball of filler/ product crystallised in her lips, under the skin (product distribution issue) was assessed as necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. The device history record could not be reviewed as the lot number was not reported.
Patient Sequence No: 1, Text Type: N, H10
[186601902]
This report is related to mdr 3013840437-2020-00033, referring to the same patient. This report was received from a uk consumer via an article published in the sun and concerns a (b)(6) year-old female patient. She was injected with radiesse? Into lips, by an unqualified beautician. The patient was reportedly injected about 20 times during the session. Straight away after the radiesse? Injection, the patient experienced an unbearable pain (considered as severe). Her lips were stinging and swelled up straight away. She was worried as they were so huge and painful, her top lip was almost touching her nose. The injector insisted that they would go down, and advised the patient to go home and put ice on them, which did not do anything. The patient reportedly looked horrific. She could hardly talk, eat or drink. Within a couple of days after the radiesse? Injection, giant lumps appeared which meant she could hardly open her mouth. There was a giant ball of filler on the patients bottom lip and her top one had lumps either side, with a huge gap where there was no filler in the middle. The patient looked so bad, she could not go to work and hid at home with a scarf around her face. The patient went back to see the injector, who injected the patient with more filler, to even out the patients pout, as the patient was desperate to look normal. After the corrective treatment the patients lips were left looking even worse. The patient was angry and upset because she looked so awful. The patient was asking the injector of what she could do, but the injector just kept telling her to wait for the swelling to go down, and reportedly then blocked the patient. The patient really began to panic and though she was going to be stuck like this forever. As corrective treatment the patient was taking antihistamine and putting ice on her lips, but nothing was making any difference, they were filled with lumps of all sizes that were noticeable when she spoke. The patient went to see a reconstructive surgeon, who reportedly never saw anything like it. In his opinion, the wrong technique was used, which had compromised the blood vessels to her lips. Reportedly the calcium-based product crystallised in her lips, under the skin. The physician tried to dissolve the radiesse? , but it had no effect on the lumps, so he cut into her lips under local anaesthetic, picked out the lumps with scissors and stitch her lips back up. The surgery took two hours and the physician had to be careful not to take away too much lip tissue and only the calcium. Reportedly, the patient underwent two operations. It took two months for the patients lips to heal before being corrected. The physician used revolax? To make the patients lips even and restore volume, as well as vertical tenting injections to stop the safe dermal filler from spreading above the lip. At the time of this report, the patient still had some tiny lumps she was able to feel, as the physician could not get everything out, but the lips looked so much better. The patient also had scar tissue at the corner of her mouth, where the big lumps were. It was also reported that the patients lips returned back to normal. Due to the provided information the outcome of the events compromised the blood vessels, unbearable pain/ lips were stinging and lips swelled up was considered as resolved, and the outcome of the event giant lumps/ giant ball of filler/ product crystallised in her lips, under the skin was considered as resolving.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013840437-2020-00041 |
| MDR Report Key | 9877403 |
| Report Source | CONSUMER,FOREIGN,LITERATURE |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-25 |
| 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 | 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 | 2020-03-25 |
| 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 | 2020-03-25 |