MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-19 for MORIA HANNA TREPHINE BLADE 8.0 17171E * manufactured by Moria Usa.
[620557]
Patient with a right corneal edema from a corneal transplant graft injection was admitted for a right corneal endothelial cell transplantation. The trephine blade had a burr on it, which was unknown to staff. During the button punch, the tissue became incarcerated in the blade defect with immediate loss of suction, which caused the graft to experience the soft contact lens "shrivel. " after more gentle attempts at freeing the graft from the blade, the physician used forceps to free the graft from the blade. The leg of the peripheral donor is labeled with an 'l' which helps determine if the graft flips. Unfortunately, the 'l' was cut off by the smaller than usual punch size. There is a 50/50 chance that the graft is implanted upside down. The graft is 100% attached, but still swollen. Patient will be seen later this month for further re-evaluation purposes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 845711 |
| MDR Report Key | 845711 |
| Date Received | 2007-04-19 |
| Date of Report | 2007-04-19 |
| Date of Event | 2007-04-12 |
| Report Date | 2007-04-19 |
| Date Reported to FDA | 2007-04-19 |
| Date Added to Maude | 2007-05-10 |
| 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 |
| 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 | MORIA HANNA TREPHINE BLADE 8.0 |
| Generic Name | BLADE |
| Product Code | HRH |
| Date Received | 2007-04-19 |
| Returned To Mfg | 2007-04-01 |
| Model Number | 17171E |
| Catalog Number | * |
| Lot Number | TRE253 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 832798 |
| Manufacturer | MORIA USA |
| Manufacturer Address | 1050 CROSS KEYS DRIVE DOYLESTOWN PA 18902 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-19 |