MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-08 for REN? GEL, 1.5CC 08-015-00-V04 manufactured by Cytophil, Inc..
[132555725]
Cytophil, inc. Reviewed the manufacturing, sterilization, and post-sterilization records for ren? Gel lot y708-00047. This review confirmed that all devices were manufactured in accordance with specifications. The physician reported that the ren? Gel, 1. 5cc device associated with the (b)(6) 2018 injection had been discarded and was not available for evaluation. Cytophil, inc. Has reviewed its complaint files for any similar type complaints, both for the reported lot, and for all production lots dating back to 2015. There have been no other complaint reports received by cytophil of vocal fold stiffness post-injection, with ren? Injectable products. The complaint investigation is on-going. A supplemental report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[132555726]
The patient was reported to have been diagnosed with right vocal fold paresis via a videostroboscopy performed on (b)(6) 2018. The etiology of the paresis is unknown. On (b)(6) 2018, the patient underwent percutaneous injection with 0. 6 cc of ren? Gel through the cricothyroid. The physician reported that the patient was moving and coughing during the procedure. The physician confirmed that the patient was able to phonate on (b)(6) 2018 via an exam following the injection. The patient's voice was described as "hoarse dysphonia" and the patient's exam was noted to be "within normal limits. " the patient was seen for follow-up on (b)(6) 2018. The physician reported that the patient presented with "decreased amplitude of the mucosal wave and ecchymosis on the right vocal fold. " the ecchymosis was reported to have resolved and unilateral (right side only) vocal fold stiffness was noted during an additional follow-up visit on (b)(6) 2018. The vocal fold stiffness was reported to have been diagnosed via a videostroboscopy and through listening to the patient's voice. During the (b)(6) 2018 follow-up appointment, the physician noted that there had been "interval decrease in vocal fold size and mild improvement in the mobility of the vocal fold. " the patient's vocal quality was noted as "sharp and dysphonic" with "diplophonia in the low ranges. " no further treatment was reported but the physician stated that "both speech therapy and microflap excision of the remaining injection material" were offered "which the patient has deferred. " the patient's current status was reported that he "remains with vocal fold stiffness" and that "he does not wish to pursue further treatment. " a follow-up appointment was scheduled for (b)(6) 2019 but the patient was reported to have cancelled due to "other health concerns. " the physician reported that the patient plans to follow-up to evaluate whether the vocal fold stiffness is permanent but wishes to defer the follow-up at this time for several months. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007225376-2019-00001 |
| MDR Report Key | 8229240 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-08 |
| Date of Report | 2019-02-11 |
| Date of Event | 2018-10-10 |
| Date Mfgr Received | 2018-12-10 |
| Device Manufacturer Date | 2017-12-27 |
| Date Added to Maude | 2019-01-08 |
| 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? GEL, 1.5CC |
| Generic Name | SYSTEM, VOCAL CORD MEDIALIZATION, PRODUCT CODE: MIX |
| Product Code | MIX |
| Date Received | 2019-01-08 |
| Model Number | 08-015-00-V04 |
| Lot Number | Y708-00047 |
| 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. Other | 2019-01-08 |