MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-02-14 for SUPERBLADE TREPHINE 15-0140-75 manufactured by Pharmacia Ophthalmics.
[15604724]
Actual size imprinted on trephine was 7. 5 mm, size shown on container was 8. 5 mm. This wasn't discovered until physician had cut donor cornea and then realized that the cornea implant wouldn't fit. Implant had to be removed and pt's own cornea reinserted. Under a separate procedure, a second donor cornea had to be cut to fit the 7. 5 mm incision and was implanted. Packaging of trephine is in two parts. Outside box displays product size, inside bubble pack doesn't display size. Outside box isn't secure in any way to prevent it from being opened prior to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 32704 |
| MDR Report Key | 32704 |
| Date Received | 1996-02-14 |
| Date of Report | 1995-12-01 |
| Date of Event | 1995-11-29 |
| Date Facility Aware | 1995-11-29 |
| Report Date | 1995-12-01 |
| Date Reported to Mfgr | 1995-12-04 |
| Date Added to Maude | 1996-05-08 |
| 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 |
| 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 | SUPERBLADE TREPHINE |
| Generic Name | SURGICAL KNIFE |
| Product Code | HRG |
| Date Received | 1996-02-14 |
| Catalog Number | 15-0140-75 |
| Lot Number | 8806213 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 33984 |
| Manufacturer | PHARMACIA OPHTHALMICS |
| Manufacturer Address | PO BOX 5036 MONROVIA CA 910177136 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1996-02-14 |