MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-04-08 for KELLAN NUCLEUS SEGMENTER E0521 manufactured by Bausch & Lomb.
[16404001]
The tip of the instrument broke off while in the eye. The tip was removed with no injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[16530207]
The instrument has been physically damaged. The tip is bent and broken. This reusable device is more than three years old.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1920664-2009-00098 |
| MDR Report Key | 1419140 |
| Report Source | 06 |
| Date Received | 2009-04-08 |
| Date of Report | 2009-03-24 |
| Date of Event | 2009-03-24 |
| Date Mfgr Received | 2009-03-24 |
| Date Added to Maude | 2009-08-19 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JANET LACAVICH |
| Manufacturer Street | 3365 TREECOURT INDUSTRIAL BLVD |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263213 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KELLAN NUCLEUS SEGMENTER |
| Product Code | HNQ |
| Date Received | 2009-04-08 |
| Returned To Mfg | 2009-03-31 |
| Model Number | NA |
| Catalog Number | E0521 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2009-04-08 |