MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-12 for SCIENTRONICS SERIES 10K EYE MAGNET manufactured by Bausch & Lomb Storz Instruments.
[20201754]
While using the magnet in surgery to retrieve a metal fragment from patient's eye the magnet failed. We let the magnet cool for twenty minutes at a time and continued using, until the foreign body was removed. It was the only means of retrieving the foreign body in the patient's eye. The patient was not physically harmed, but it did extend his operating time by several hours.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005896 |
| MDR Report Key | 1013935 |
| Date Received | 2008-03-12 |
| Date of Report | 2008-03-12 |
| Date of Event | 2008-02-27 |
| Date Added to Maude | 2008-03-24 |
| 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 | RISK MANAGER |
| 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 | SCIENTRONICS SERIES 10K EYE MAGNET |
| Generic Name | 10K EYE MAGNET |
| Product Code | HPO |
| Date Received | 2008-03-12 |
| Model Number | 10K |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 983594 |
| Manufacturer | BAUSCH & LOMB STORZ INSTRUMENTS |
| Manufacturer Address | 180 VIA VERDE DR SAN DIMAS CA 91773 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2008-03-12 |