MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-20 for EPISIL MOUTH / THROAT LIQUID 10 ML manufactured by Camurus Ab / R-pharm Us Llc.
[114823212]
The pt's caregiver reported that the pt discontinued use of the product due to a lack of efficacy. Dose or amount: press pump and apply stream to; frequency: use 2-3 times; route: switch and spit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078498 |
| MDR Report Key | 7709833 |
| Date Received | 2018-07-20 |
| Date of Report | 2018-06-01 |
| Date of Event | 2018-05-01 |
| Date Added to Maude | 2018-07-23 |
| 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 | PHARMACIST |
| 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 | EPISIL MOUTH / THROAT LIQUID 10 ML |
| Generic Name | DRESSING, WOUND AND BURN |
| Product Code | MGQ |
| Date Received | 2018-07-20 |
| Lot Number | TK0155D |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAMURUS AB / R-PHARM US LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-20 |