MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-12-11 for PULSE LITE LEAD GLASSES PL 100 S * manufactured by Pulse Medical, Inc.
[543417]
Md - radiologist- put on safety glasses in medical imaging special procedures room; attempted to adjust them, when the right lens broke and sliver of glass allegedly went into right eye. Md went to ed immediately; eye was flushed and numbed, and md was ordered to see an ophthalmologist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1041329 |
| MDR Report Key | 793011 |
| Date Received | 2006-12-11 |
| Date of Report | 2006-12-11 |
| Date of Event | 2006-12-11 |
| Date Added to Maude | 2006-12-13 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PULSE LITE LEAD GLASSES |
| Generic Name | LEAD GLASSES |
| Product Code | IWS |
| Date Received | 2006-12-11 |
| Model Number | PL 100 S |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 780645 |
| Manufacturer | PULSE MEDICAL, INC |
| Manufacturer Address | 4131 SW 47TH AVE STE 1405 DAVIE FL 33314 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-12-11 |