MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-04-12 for STORTZ E-4210 manufactured by Bausch & Lomb Surgical.
[3256566]
Tip of lacrimal probe broke off during use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3031264 |
| MDR Report Key | 3031264 |
| Date Received | 2006-04-12 |
| Date of Report | 2006-04-06 |
| Date of Event | 2006-03-31 |
| Date Facility Aware | 2006-03-31 |
| Report Date | 2006-04-06 |
| Date Reported to FDA | 2006-04-10 |
| Date Added to Maude | 2013-04-03 |
| 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 | STORTZ |
| Generic Name | LACRIMAL PROBE |
| Product Code | HNL |
| Date Received | 2006-04-12 |
| Model Number | E-4210 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH & LOMB SURGICAL |
| Manufacturer Address | 3365 TREE COURT INDUSTRIAL BLVD. ST. LOUIS MO 62122621 US 62122 6215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-04-12 |