MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-01-05 for ECKERD * manufactured by Optico/flent.
[215869]
Pt had an earplug melt inside ear causing them to go through two emergency surgeries in a one week period. Also causing pt an ear infection and severe pain and bleeding. Roll into ball between palms of hands, place in clean dry ear, until plug feels secure, yet comfortable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1020787 |
| MDR Report Key | 311550 |
| Date Received | 2001-01-05 |
| Date of Report | 2001-01-05 |
| Date of Event | 2000-07-19 |
| Date Added to Maude | 2001-01-11 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECKERD |
| Generic Name | SOFT SILICONE EARPLUGS |
| Product Code | FWD |
| Date Received | 2001-01-05 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | 34575 55393 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 301345 |
| Manufacturer | OPTICO/FLENT |
| Manufacturer Address | 17 HUNTERSRIDGE SAGINAW MI 48603 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2001-01-05 |