MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-25 for MARCO NIDEK L 500 RT - 5100, REFRACTOR manufactured by Marco Technology.
[18298135]
Physician was doing an eye exam. When moving the phoropter, the near point rod fell down and hit the bridge of her nose and she obtained a laceration. The most recent maintenance was performed on (b)(4) 2013 by our clinical technology dept. The near point rod was properly tight and secure upon inspection today, (b)(4) 2013. Since maintenance was performed on (b)(4) 2013 and it was still tight today, (b)(4) 2013, the near point rod had to have been properly tight on the day of the incident, (b)(4) 2013. It has been a constant issue trying to obtain parts for this device for our scheduled maintenance checks from this manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5033133 |
| MDR Report Key | 3493718 |
| Date Received | 2013-11-25 |
| Date of Report | 2013-11-22 |
| Date of Event | 2013-11-16 |
| Date Added to Maude | 2013-12-02 |
| 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 | MARCO NIDEK L 500 |
| Generic Name | MARCO NIDEK L 500 |
| Product Code | HKN |
| Date Received | 2013-11-25 |
| Model Number | RT - 5100, REFRACTOR |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MARCO TECHNOLOGY |
| Manufacturer Address | JACKSONVILLE FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-25 |