MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-30 for PRO FIT EARPLUGS 400772 manufactured by Health Enterprises Inc..
[2452675]
I have a pt who tried to use this product and the putty mixture went down into his ear canal. This product is currently sold over the counter and i do not believe it is appropriate as currently described. The mixture does not set as a mold and it runs down into the ear canal when set.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023706 |
| MDR Report Key | 2401030 |
| Date Received | 2011-12-30 |
| Date of Report | 2011-12-30 |
| Date of Event | 2011-12-19 |
| Date Added to Maude | 2012-01-09 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRO FIT EARPLUGS |
| Generic Name | CUSTOM MOLD EARPLUGS |
| Product Code | EWD |
| Date Received | 2011-12-30 |
| Model Number | 400772 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEALTH ENTERPRISES INC. |
| Manufacturer Address | 90 GEORGE LEVEN DR NORTH ATTLEBORO MA 02760 US 02760 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2011-12-30 |