MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-24 for PROLARYN GEL manufactured by Merz Neurosciences.
[46271413]
Pt developed respiratory distress requiring intubation 24 hours following injection of prolaryn gel injection to the interarytenoid space. Pt was intubated for 4 days and eventually extubated without complication today. Dose or amount: 0. 3 ml; frequency: once; route: submucous; dates of use: (b)(6) 2016; reason for use: pharyngeal dysphagia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062519 |
| MDR Report Key | 5688257 |
| Date Received | 2016-05-24 |
| Date of Report | 2016-05-24 |
| Date of Event | 2016-05-19 |
| Date Added to Maude | 2016-05-31 |
| 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 |
| 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 | PROLARYN GEL |
| Generic Name | PROLARYN GEL |
| Product Code | OGR |
| Date Received | 2016-05-24 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERZ NEUROSCIENCES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-05-24 |