MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-07-31 for PROLARYN GEL INJECTABLE IMPLANT manufactured by Merz North America, Inc..
[115671890]
This case was assessed as reportable to the fda as the event was deemed to meet serious injury criteria. The device history record could not be reviewed as the lot number was not reported.
Patient Sequence No: 1, Text Type: N, H10
[115671891]
This spontaneous report was received from a medical assistant and clinical manager of a physician's practice and concerns a (b)(6) male patient who presented for injection of prolaryn voice gel for vocal cord paralysis on (b)(6) 2018. Medical history and concomitant medications reported as none. While the physician was trying to insert the 27g needle, the needle broke off in the soft tissue of the larynx, in the mucosa just above the left vocal cord, coming out of the soft vocal cord. No product was injected. The physician attempted to remove the needle in the office but it was too deep. The patient was transported to the hospital, where he underwent surgical removal of the needle. While the patient was still under sedation, he was successfully injected with prolaryn voice gel. The patient was placed on keflex (cephalexin) post operatively. The patient presented for follow up on (b)(6) 2018 and was fine. There were no sequelae from the event. Causality reported as related. The lot number was unknown as the syringe was disposed of and the lot number was not recorded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135225-2018-00035 |
| MDR Report Key | 7736660 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-31 |
| Date of Report | 2018-07-31 |
| Date of Event | 2018-07-05 |
| Date Mfgr Received | 2018-07-19 |
| Date Added to Maude | 2018-07-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| 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 GEL INJECTABLE IMPLANT |
| Generic Name | SYSTEM, VOCAL CORD MEDIALIZATION |
| Product Code | MIX |
| Date Received | 2018-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERZ NORTH AMERICA, INC. |
| Manufacturer Address | 4133 COURTNEY STREET, SUITE 10 FRANKSVILLE WI 53126 US 53126 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-31 |