MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-10-19 for BIONIX LIGHTED MICROLOOP 2220 manufactured by .
[20512035]
Staff were trying new lighted ear curette on sally to see how it worked before using on resident of facility. Long plastic curette attaches to light source, did not attach securely and it became projectile and shot into sally's ear puncturing her ear drum. Company called and stated this has happened before to another customer. Exact brand bionix lighted microloop 3mm diameter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004151 |
| MDR Report Key | 931755 |
| Date Received | 2007-10-19 |
| Date of Report | 2007-10-19 |
| Date of Event | 2007-10-05 |
| Date Added to Maude | 2007-11-07 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | BIONIX LIGHTED MICROLOOP |
| Generic Name | EAR CURETTE |
| Product Code | JYG |
| Date Received | 2007-10-19 |
| Model Number | 2220 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 906692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2007-10-19 |