MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-10-18 for TANO DIAMOND DUSTED MEMBRANE SCRAPER * 20.04 manufactured by Synergetics, Inc..
[21615608]
Plastic tip at end of tano diamond dusted membrane scraper broke off in the patient's right eye. Dr. Was able to retrieve the end with mini diamond forceps. No problems noted. Patient went home later that day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 778830 |
| MDR Report Key | 778830 |
| Date Received | 2006-10-18 |
| Date of Report | 2006-10-18 |
| Date of Event | 2006-08-31 |
| Report Date | 2006-10-18 |
| Date Reported to FDA | 2006-10-18 |
| Date Added to Maude | 2006-11-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | TANO DIAMOND DUSTED MEMBRANE SCRAPER |
| Generic Name | PROBE, LASER, OCULAR |
| Product Code | HNL |
| Date Received | 2006-10-18 |
| Model Number | * |
| Catalog Number | 20.04 |
| Lot Number | 5040140 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 766609 |
| Manufacturer | SYNERGETICS, INC. |
| Manufacturer Address | 3845 CORPORATE CENTRE DRIVE ST. CHARLES MO 63304 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-18 |