MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-04-27 for STIFF 25GA TANO DIAMOND DUSTED MEMBRANE SCRAPER * 20.04.25S manufactured by Synergetics, Inc..
[1204055]
Patient undergoing pars plana vitrectomy with membrane peel of the left eye. A stiff 25 gauge tano diamond dusted membrane scraper came apart while being used during the procedure. No harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1379773 |
| MDR Report Key | 1379773 |
| Date Received | 2009-04-27 |
| Date of Report | 2009-04-27 |
| Date of Event | 2009-02-26 |
| Report Date | 2009-04-27 |
| Date Reported to FDA | 2009-04-27 |
| Date Added to Maude | 2009-05-13 |
| 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 | 0 |
| 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 | STIFF 25GA TANO DIAMOND DUSTED MEMBRANE SCRAPER |
| Generic Name | PROBE, LACHRYMAL |
| Product Code | HNL |
| Date Received | 2009-04-27 |
| Model Number | * |
| Catalog Number | 20.04.25S |
| Lot Number | 8100262 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGETICS, INC. |
| Manufacturer Address | 3845 CORPORATE CENTER DRIVE O'FALLON MO 63368 US 63368 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-27 |