MAUDE Adverse Event Report: CYTOPHIL, INC. RENU VOICE, 1.5CC; SYSTEM, VOCAL CORD MEDIALIZATION

Model Number	08-015-04-V04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient identifier will not be reported by the physician.This injection procedure information was provided to cytophil, inc.As part of a retrospective data collection/review for a post-market clinical follow-up (pmcf) study.The center's investigation review board (irb) requires patient personal identification information not be shared.The center reported the patient was receiving adjuvant hormonal therapy at the time of the procedure and post-injection and has cutaneous squamous cell carcinoma of parotid.No additional therapy for the voice was noted as being performed and the patient's voice is still reported to have "roughness" and finds it "harder/more difficult to speak." cytophil has concluded its complaint investigation.Cytophil is unable to definitively determine the root cause of the reported incident.The device was reported as discarded and was therefore unavailable for return and no retain samples were evaluated.Product labeling and risk management contain appropriate information regarding insufficient correction and poor voice quality.A review of complaint records revealed seven (7) additional complaints where the patient reported similar outcomes in post-injection, no trending has been identified.The results of cytophil's review of the pertinent renú voice device manufacturing records confirm the devices were manufactured in accordance with specifications.Each patient case is unique for required volume to achieve correction.It cannot be determined if the renú injection procedure/implant caused the reported outcome, if it was an underlying condition, or other on-going therapy.The event was not reported to cytophil when it occurred.The physician is to be counseled about reporting complaints and adverse events to cytophil.The complaint is being closed and will be tracked and trended.
Event or Problem Description
The patient underwent an uneventful an operating room (or) transoral injection of renú voice into both the left and right vocal folds on (b)(6) 2019 for left vocal fold paralysis and right vocal fold atrophy using a renú transoral needle.0.35 ml of product was injected into each vocal fold.No procedural complications were noted.During a follow-up appointment on (b)(6) 2019 the physician reported the immobility of the left vocal fold remained unchanged and no improvement in the ability to increase volume, but the dysphonia and the voice quality/phonation improved.The patient reported her voice was "different", roughness, no change in volume, and it was harder/more effortful to speak.(ref.(b)(4)).

• Brand Name: RENU VOICE, 1.5CC
• Common Device Name: SYSTEM, VOCAL CORD MEDIALIZATION
• Manufacturer (Section D): CYTOPHIL, INC.; 2485 corporate circle; suite 2; east troy, wi
• MDR Report Key: 10311922
• Report Number: 3007225376-2020-00007
• Device Sequence Number: 16988392
• Product Code: MIX
• UDI-Device Identifier: 00856509002294
• UDI-Public: (01)00856509002294(10)Z908-00076(17)210216
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2021
• Device Model Number: 08-015-04-V04
• Device Catalogue Number: 08-015-04-V04
• Device Lot Number: Z908-00076
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 53