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 |