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 2018-03-23 for REN? GEL, 1.5CC 08-015-00-V04 manufactured by Cytophil, Inc..
[103401990]
Cytophil reviewed the manufacturing, sterilization and post sterilization testing records for renu gel lot # s708-00035. This review confirmed that all devices were manufactured in accordance with specifications and there were no issues identified with the manufacturing of this lot. The surgery center advised that there is no product associated with the (b)(6) 2018 renu gel injection available for evaluation. The facility also advised that other renu gel devices from lot # s708-00035 have been set aside and are being held, pending approval from their legal counsel to have a local laboratory perform cultures on these devices. Cytophil has requested additional information from the surgery center, i.. E, a copy of the laboratory culture report from the (b)(6) 2018 incision and drainage, additional information specific to the patient and the reported event, the manufacturer/model of the laryngoscope and microscope used during the (b)(6) procedure, and whether any other infections have been reported at the facility on or around the time of the patient's injection. Cytophil reviewed its complaint files. There have been no reported complaints related to infection or other patient reactions, for this lot, nor for any other lot of renu gel or transoral needle product manufactured to date, by cytophil. This complaint investigation is ongoing. A supplemental report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[103401991]
It was reported that on (b)(6) 2018, the patient underwent an uneventful diagnostic laryngoscopy with an anterior commissure laryngoscope (microscope aided) injection of ren? Gel in the mid and anterior portions of the right vocal cord, for left true cord vocal paresis. The patient has a history of type 1 diabetes, graves disease (with tachycardia) and residual left vocal cord paresis following a (b)(6) 2017 thyroidectomy. It was reported that the ren? Gel product pouch was in intact when it was opened in a surgical center operating room, just prior to the injection. Approximately 1cc of the ren? Gel product was reported to have been delivered via a ren? Transoral needle. No noted difficulties were reported to have been experienced during the procedure. Within 24 hours of the (b)(6) 2018 injection, the patient reportedly began exhibiting symptoms of a site infection. Post op day 1 ((b)(6) 2018): "significant neck swelling anteriorly just under her previous thyroidectomy incision" post op day 4 ((b)(6) 2018) : "increase in swelling, cord slight erythema, no endolaryngeal reaction to note. Treated with steroids and antibiotics" post op day 6 ((b)(6) 2018): "unable to swallow antibiotics due to swelling, progressive neck swelling, firmer. Admitted to the hospital for iv antibiotics, ct scan, and cultures. Ct scan demonstrated large peripherally enhancing focal fluid collection suspicious for abscess. " at 2200, "underwent surgical incision and drainage of anterior neck abscess, approximately 50 cc of purulent, foul smelling material. " the patient's current condition was reported to be "improving, small-moderate neck tenderness and increased vocal hoarseness (as compared to pre-renu injection). " ((b)(4)) (ren? Transoral needle mfr. Report #: 3007225376-2018-00002).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007225376-2018-00001 |
| MDR Report Key | 7366257 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-03-23 |
| Date of Report | 2018-04-26 |
| Date of Event | 2018-01-26 |
| Date Mfgr Received | 2018-03-28 |
| Device Manufacturer Date | 2017-06-21 |
| Date Added to Maude | 2018-03-23 |
| 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 |
| Date Received | 2018-03-23 |
| Model Number | 08-015-00-V04 |
| Lot Number | S708-00035 |
| Device Expiration Date | 2019-06-21 |
| 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 531202745 US 531202745 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-03-23 |