MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-22 for REN? VOICE 08-015-04-V04 manufactured by Cytophil, Inc..
[83530100]
The physician was able to successfully complete the procedure with the material provided in the syringe. The device was not returned to cytophil for evaluation. Additional information regarding the reported complaint is being requested from the physician. The investigation is ongoing; a supplemental report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[83530101]
The physician reported that upon opening the renu voice, it was discovered that the product syringe was under-filled. He estimated that the syringe contained approximately 50% volume. The physician also indicated that there was no evidence of product leakage within the sterile pouch. The physician stated that there was no patient impact as the volume in the syringe was sufficient to successfully complete the procedure. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007225376-2017-00002 |
| MDR Report Key | 6810939 |
| Date Received | 2017-08-22 |
| Date of Report | 2017-09-26 |
| Date Mfgr Received | 2017-09-25 |
| Device Manufacturer Date | 2015-03-27 |
| Date Added to Maude | 2017-08-22 |
| 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 | 0 |
| Brand Name | REN? VOICE |
| Generic Name | SYSTEM, VOCAL CORD MEDIALIZATION |
| Product Code | MIX |
| Date Received | 2017-08-22 |
| Model Number | 08-015-04-V04 |
| Lot Number | P508-00002 |
| Device Expiration Date | 2017-03-27 |
| 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 | 2017-08-22 |