MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-04-14 for STORZ * manufactured by Bausch And Lomb.
[5916527]
During lacrimal duct dilation and probing with possible stent placement, the physicians noted small metal fragments on the inside of the eye as well as in the lacrimal duct. It was found to be coming off of one of the lacrimal dilators. The physicians were able to remove fragments from the eye and lacrimal duct so the patient did not sustain any injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4804313 |
| MDR Report Key | 4804313 |
| Date Received | 2015-04-14 |
| Date of Report | 2015-04-14 |
| Date of Event | 2015-04-07 |
| Report Date | 2015-04-14 |
| Date Reported to FDA | 2015-04-14 |
| Date Reported to Mfgr | 2015-05-29 |
| Date Added to Maude | 2015-05-29 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | STORZ |
| Generic Name | LACRIMAL DUCT DILATOR |
| Product Code | HNW |
| Date Received | 2015-04-14 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH AND LOMB |
| Manufacturer Address | 1400 NORTH GOODMAN ST. ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-14 |