MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2014-03-13 for RADIESSE VOICE 8044M0 manufactured by Merz North America Inc..
[4289615]
A (b)(6) male with no known food or airborne allergies underwent esophagotomy with mediastinal lymph node dissection for squamous cell carcinoma. Post operatively, he complained of hoarseness, decreased vocal projection, cough, and dysphagia and was found to have a left vocal cord paresis. Seventeen days after surgery, he underwent uncomplicated injection augmentation in the office under topical and local anesthesis, using a total of 0. 5cc of carboxymethylcellulose. One year later, his paresis had progressed to a frank paralysis due to recurrent carcinoma in the mediastinum. His voice was again breathy and his cough had returned. Given his overall prognosis, repeat injection augmentation with a longer-lasting material was recommended. Prior to the procedure, the patient took 5mg of zolpidem for relaxation. A 1cc of 1% lidocaine with epinephrine 1:100,000 was injected subcutaneously near the cricothyroid space. Additionally, pledgets with topical 2% lidocaine and phenylephrine were placed in the nose. After several minutes, augmentation was performed percutaneously under flexible laryngoscopic control without difficulty. A total of 0. 7cc pf caha was used. He tolerated the procedure well and was discharged after 20 minutes of observation. Ten minutes later, he developed diffuse, severe itchiness and his wife noticed hives on his chest. She immediately returned him to the office. He denied respiratory difficulty but complained of a sudden feeling of fatigue and malaise. Additionally, while he had no respiratory noise, his voice had become low-pitched and rough. Examination revealed mild tachycardia with normal blood pressure, diffuse urticaria and marked facial erythema and edema. His eyelids had swollen shut. An allergy specialist within the same department was immediately consulted and a diagnosis of anaphylaxis was made. After placing the patient in a recumbent position, 0. 3mg of epinephrine (1:1000) was given intramuscularly in addition to supplemental oxygen. His vital signs remained stable and his urticaria started to improve. He was transferred to the emergency department, where he received intravenous hydration, diphenhydramine, dexamethasone and continued observation for late-phase reaction. His symptoms resolved after 6 hours and he was discharged with no further complications. Follow up examination 2 weeks later showed no sign of residual edema with adequate airway. Glotic insufficiency was well-addressed by the injection. The lot number of the radiesse voice was not provided in the article.
Patient Sequence No: 1, Text Type: D, B5
[11615547]
The laryngoscope 123: 2237-2239, 2013. September 2013 cohen et al: severe systemic reaction from calcium hydroxylapatite vocal fold filler. Justin c cohen, md, william reisacher, md, melanie malone, md, lucian sulica, md.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2135225-2014-00017 |
| MDR Report Key | 3690791 |
| Report Source | 03 |
| Date Received | 2014-03-13 |
| Date of Report | 2014-02-11 |
| Date Mfgr Received | 2014-02-11 |
| Date Added to Maude | 2014-04-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANN METZ |
| Manufacturer Street | 4133 COURTNEY ROAD SUITE 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 VOICE |
| Generic Name | INJECTABLE IMPLANT |
| Product Code | KHJ |
| Date Received | 2014-03-13 |
| Catalog Number | 8044M0 |
| Lot Number | UNK |
| 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 | FRANKSVILLE WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-03-13 |