MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-10-06 for REN? VOICE, 1.5CC 08-015-04-V04 manufactured by Cytophil, Inc..
[89940525]
Cytophil requested and received additional information regarding the event and the patient's current status. Regarding the event, the physician's office reported that the crack occurred at the "hub of the syringe, where the needle attaches. " following the procedure, the patient returned for a follow up appointment on (b)(6) 2017. During that office visit, the physician reported that there was "arthyenoid movement bilateral; still with persistent glottis gap. " the physician recommended that the patient seek a second opinion. The patient is scheduled to return for a follow up appointment on (b)(6) 2017. Cytophil requested and received the device for evaluation. The device was returned to cytophil, and was evaluated "as received" under 50x magnification. It was then carefully rinsed and viewed again under 50x magnification. There was no visible defect viewed under magnification. The syringe was then filled with water as a worst case test, and tested under pressure, with no leakage occurring. The device performed according to specification and was determined to have not cracked, as reported. Cytophil did not receive the needle for evaluation. A review of the device history records did not reveal any irregularities or issues with syringes. Cytophil will provide a supplemental report after the patient's (b)(6) 2017 appointment.
Patient Sequence No: 1, Text Type: N, H10
[89940526]
During a renu voice procedure, the physician performed an initial injection of the renu voice material into the patient's vocal fold without any reported issue. It was reported by the physician's nurse manager that the physician then attempted to inject additional material from this same syringe, and the syringe "cracked. " it was also reported that the syringe did not then contain enough material to complete the patient's procedure. Since the physician's office did not have an additional renu voice devices available for use during the patient's procedure, the nurse manager "believes" that the patient was offered the opportunity to continue and complete the procedure at the hospital where additional renu voice products were available for use, however the patient declined to complete the procedure at the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007225376-2017-00004 |
| MDR Report Key | 6925638 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-10-06 |
| Date of Report | 2017-10-16 |
| Date of Event | 2017-09-07 |
| Date Mfgr Received | 2017-10-12 |
| Device Manufacturer Date | 2017-04-18 |
| Date Added to Maude | 2017-10-06 |
| 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 |
| Date Received | 2017-10-06 |
| Returned To Mfg | 2017-09-21 |
| Model Number | 08-015-04-V04 |
| Lot Number | Q708-00031 |
| Device Expiration Date | 2019-04-18 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-10-06 |