MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-06-19 for 25GA STELLARIS PC VITRECTOMY PROBE BL5625S manufactured by Bausch + Lomb.
| Report Number | 0001932402-2019-00003 |
| MDR Report Key | 8711557 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-06-19 |
| Date of Report | 2019-05-28 |
| Date of Event | 2019-05-28 |
| Date Added to Maude | 2019-06-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MS. JULI MOORE |
| Manufacturer Street | 3365 TREE COURT INDUSTRIAL BLV |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263220 |
| Manufacturer G1 | SYNERGETICS |
| Manufacturer Street | 3345 CORPORATE CENTRE DR. |
| Manufacturer City | O''FALLON MO 63368 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63368 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 25GA STELLARIS PC VITRECTOMY PROBE |
| Generic Name | UNIT, PHACOFRAGMENTATION |
| Product Code | HQE |
| Date Received | 2019-06-19 |
| Returned To Mfg | 2019-06-13 |
| Model Number | BL5625S |
| Lot Number | M0005808 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-19 |