MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-01-23 for PROLARYN PLUS INJECTABLE IMPLANT manufactured by Merz North America.
[98013913]
The case was assessed as reportable to the fda. The device history record could not be reviewed as the lot number was not provided.
Patient Sequence No: 1, Text Type: N, H10
[98013914]
This spontaneous report was received from a south african physician and concerns a patient. The patient was injected with prolaryn? Plus into the vocal cord. The surgeon may have over delivered prolaryn? Plus into a vocal cord and inquired recommendations regarding the procedure for surgical retrieval of the excess of product. Follow-up information was received on 15-jan-2018: the case was upgraded to serious. The events "foreign material with surrounding fibrosis" and "minimal foreign body granulomatous reaction" were added. Event term "delivered prolaryn? Plus into a vocal cord" was changed to "delivered prolaryn? Plus into a vocal cord/over injected/possibly overfull" and this event was considered serious. The case concerns a female patient. She was injected with prolaryn? Plus lateral to the vocal fold to improve voice. In the opinion of a surgeon, the product was incorrectly and over-injected, possibly overfull and a bit superficial. The patient's medical history included left vocal fold palsy. A few hours after the treatment with prolaryn? Plus, the patient had a reaction but went home the same day. At four months post injection, the second surgeon tried to resect prolaryn? Plus via a lateral (thyroidectomy) approach. He stated that the patient had fibrosis and her voice was always going to be hoarse. Therefore, the outcome of this event was deemed not recovered. The histology showed fragments of voluntary muscle with focuses of foreign material with surrounding fibrosis and minimal foreign body granulomatous reaction. That was summarized as voluntary muscle with focal deposits of partially calcified foreign material. In the opinion of the reporter, the event of "minimal foreign body granulomatous reaction" was of mild intensity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135225-2018-00001 |
| MDR Report Key | 7213370 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-01-23 |
| Date of Report | 2018-02-27 |
| Date Mfgr Received | 2018-02-21 |
| Date Added to Maude | 2018-01-23 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SCOTT SYKES, MD |
| Manufacturer Street | 6501 SIX FORKS ROAD |
| Manufacturer City | RALEIGH NC 27615 |
| Manufacturer Country | US |
| Manufacturer Postal | 27615 |
| Manufacturer Phone | 9195828000 |
| Manufacturer G1 | MERZ NORTH AMERICA, INC. |
| Manufacturer Street | 4133 COURTNEY STREET SUITE 10 |
| Manufacturer City | FRANKSVILLE WI 53126 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53126 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROLARYN PLUS INJECTABLE IMPLANT |
| Generic Name | POLYMER, ENT SYNTHETIC POLYAMIDE |
| Product Code | KHJ |
| Date Received | 2018-01-23 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERZ NORTH AMERICA |
| Manufacturer Address | 4133 COURTNEY STREET SUITE 10 FRANKSVILLE WI 53126 US 53126 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-01-23 |