MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-02-09 for EAR PLUGS DISPOSABLE 6345 * manufactured by Soundguard.
[204636]
When ear plugs are compressed for insertion into the ear, the ear plug does not expand back to fit the ear canal. This does not block sound properly. "please switch back to the ear brand. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1018103 |
| MDR Report Key | 261820 |
| Date Received | 2000-02-09 |
| Date of Report | 2000-02-04 |
| Date Added to Maude | 2000-02-14 |
| 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 |
| 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 | EAR PLUGS DISPOSABLE |
| Generic Name | EAR PLUGS DISPOSABLE |
| Product Code | EWD |
| Date Received | 2000-02-09 |
| Model Number | 6345 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | 6515001376345 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 253570 |
| Manufacturer | SOUNDGUARD |
| Manufacturer Address | 15 FORTUEN RD WEST MIDDLETOWN NY 10941 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-02-09 |