MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-12 for RENU VOICE CAHA IMPLANT manufactured by Regen Scientific.
[120381803]
Pt presented to clinic after 3 days of aspiration symptoms and breathy dysphonia. Laryngoscopy was performed which showed a diagnosis of left idiopathic vocal cord paralysis. A ct of the neck and chest was performed which showed no abnormalities of the larynx, pharynx or neck masses. On (b)(6) 2018 the pt underwent general anesthesia for transoral augmentation of the left vocal cord. On (b)(6) 2018 the pt returned for a f/u appt because he had become increasing hoarse and was having profound chronic coughing at night. Laryngoscopy was performed which identified a mass on the left vocal cord. On (b)(6) 2018, the pt returned to operating room and it was identified that he had a poorly delineated bulge on the left vocal cord at the site of the previous injection. This area was firm, not consistent with a mass or tumor, ill defined boarders and appeared red and inflamed. A biopsy was sent to pathology for further evaluation. Histology identified high grade dysplasia of the mucosal surface and severe acute and chronic inflammation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079778 |
| MDR Report Key | 7872627 |
| Date Received | 2018-09-12 |
| Date of Report | 2018-09-11 |
| Date of Event | 2018-04-30 |
| Date Added to Maude | 2018-09-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RENU VOICE CAHA IMPLANT |
| Generic Name | VOCAL CORD MEDIALIZATION |
| Product Code | MIX |
| Date Received | 2018-09-12 |
| Lot Number | V708-00040 |
| Device Expiration Date | 2019-09-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REGEN SCIENTIFIC |
| Manufacturer Address | EAST TROY WI 553120 US 553120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-12 |