MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-05 for MEDTRONIC SOLAN * manufactured by Medtronic Ophthalmics: A Division Of Medtronic Xomed, Inc..
[368738]
A patient in for corneal edema, lens replacement surgery. During the surgery (after induction of anesthesia), a medtronic solan blade size 9 was used to cut the donor cornea. The blade was dull, tearing at the cornea. The doctor tried another blade (same size and brand, and again the blade was dull and donor cornea was ruined. The patient had to be kept under anesthesia for additional time while second donor cornea ordered and delivered. The doctor switched to blade size 8. 75 medtronic solan. The blade was sharp and the surgery was completed. This is the second event of this type within the last 9 months with this brand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 590509 |
| MDR Report Key | 590509 |
| Date Received | 2005-04-05 |
| Date of Report | 2005-04-05 |
| Date of Event | 2005-04-05 |
| Report Date | 2005-04-05 |
| Date Reported to FDA | 2005-04-05 |
| Date Added to Maude | 2005-04-14 |
| 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 |
| 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 | MEDTRONIC SOLAN |
| Generic Name | CORNEA BLADE |
| Product Code | HRH |
| Date Received | 2005-04-05 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 33206400 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 580361 |
| Manufacturer | MEDTRONIC OPHTHALMICS: A DIVISION OF MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR. NORTH JACKSONVILLE FL 32216 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-04-05 |