MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-09-17 for REN? VOICE, 1.5CC 08-015-04-V04 manufactured by Cytophil, Inc..
[120394350]
Cytophil, inc. Reviewed the manufacturing, sterilization and post sterilization records for ren? Voice, 1. 5cc lot v708-00040. This review confirmed that all devices were manufactured in accordance with specifications. The facility advised that there is no product associated with the (b)(6) 2018 ren? Voice, 1. 5cc injection available for evaluation, i. E. , following the implant procedure, the ren? Voice and ren? Transoral needle were both discarded. Cytophil, inc. Reviewed its complaint files from 2015 to present. This review of three year complaint data identified one ren? Voice complaint of inflammation; a complaint reported at the same time as this complaint, by the same physician. This complaint investigation is ongoing. A supplemental report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[120394351]
It was reported that when the patient presented in the clinic on (b)(6) 2018, he had been experiencing three (3) to four (4) days of breathy dysphonia and aspiration symptoms, as well as dysphagia with solids, hoarseness, and dry throat. A diagnostic laryngoscopy and ct scan were both performed on (b)(6) 2018. The diagnostic laryngoscopy was reported to show idiopathic left vocal cord paralysis and the ct scan showed no abnormalities of the larynx, pharynx or neck masses. On (b)(6) 2018, the patient underwent an uneventful transoral injection of ren? Voice for idiopathic left vocal cord paralysis. The procedure was reported to have occurred in an operating room under anesthesia using standard equipment, including a storz telescope 5mm, zero degree, camera, and dedo laryngoscope. The device packaging was intact and undamaged when opened by the physician. The ren? Voice was injected via a ren? Transoral needle and no noted difficulties were reported to have been experienced during the procedure. It was reported that during the patient's initial post-operative visit on (b)(6) 2018 a diagnostic laryngoscopy was performed. No abnormalities were reported. On (b)(6) 2018 the patient was reported to have returned to the clinic for a follow-up appointment due to increasing hoarseness and severe chronic coughing at night. A laryngoscopy was performed (b)(6) 2018. The laryngoscopy was reported to have identified a mass/"nodule of some type" on the left vocal cord. This mass/nodule was reported as a "small protrusion of mucosa/lesion which may be coming from the left ventricle and resting on the left tvc posteriorly. " it was reported that patient returned to the operating room on (b)(6) 2018 for suspension microlaryngoscopy with operating microscope and telescope and excision of left vocal cord lesion. The area was noted as a "poorly delineated bulge" and "firm, not consistent with a mass or tumor, ill-defined borders and appeared red and inflamed. " the physician's operative report is reported to have noted that "clinically this appeared to be reaction around his implant material and there were no additional lesions. The soft tissue beneath the site was palpated and was moderately firm with close proximity to the thyroarytenoid muscle. " a partial resection of area occurred and a biopsy was sent to pathology/histology for further evaluation. It was reported that the final pathology identified the specimen as high grade dysplasia of the mucosal surface and severe acute and chronic inflammation. Additionally, the physician reported that the injection material was visible by the pathologist and the overlying mucosal changes were not noted as being present before the injection. No further treatment was reported. The patient was reported to have returned to the clinic for a stroboscopy on (b)(6) 2018. It was noted that "now that some of the material and involved area has been resected, his cough is symptomatically improving. " the clinic reported that the patient is due to return for a repeat stroboscopy in 2-3 months. ((b)(4)) (ren? Transoral needle mfr. Report #: 3007225376-2018-00006).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007225376-2018-00005 |
| MDR Report Key | 7880507 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-09-17 |
| Date of Report | 2018-09-17 |
| Date of Event | 2018-05-07 |
| Date Mfgr Received | 2018-08-22 |
| Device Manufacturer Date | 2017-09-06 |
| Date Added to Maude | 2018-09-17 |
| 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 | MRS. KRISTIE SOTO |
| Manufacturer Street | 2485 CORPORATE CIRCLE SUITE 2 |
| Manufacturer City | EAST TROY WI 53120 |
| Manufacturer Country | US |
| Manufacturer Postal | 53120 |
| Manufacturer Phone | 2626422765 |
| Manufacturer G1 | CYTOPHIL, INC. |
| Manufacturer Street | 2485 CORPORATE CIRCLE SUITE 2 |
| Manufacturer City | EAST TROY WI 53120 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REN? VOICE, 1.5CC |
| Generic Name | SYSTEM, VOCAL CORD MEDIALIZATION, PRODUCT CODE: MIX |
| Product Code | MIX |
| Date Received | 2018-09-17 |
| Model Number | 08-015-04-V04 |
| Lot Number | V708-00040 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYTOPHIL, INC. |
| Manufacturer Address | 2485 CORPORATE CIRCLE SUITE 2 EAST TROY WI 53120 US 53120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-17 |