MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-03-12 for K-3000 MICROKERATOME BLADE * manufactured by Bd Ophthalmic Systems.
[315304]
Irregular flap was observed when cutting corneal flap using microkeratome. Doctor elected to postpone the lasik procedure. The flap was repositioned. Patient was sent home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226073-2003-00002 |
| MDR Report Key | 448468 |
| Report Source | 05 |
| Date Received | 2003-03-12 |
| Date of Report | 2003-03-03 |
| Date of Event | 2003-01-10 |
| Date Mfgr Received | 2003-01-10 |
| Device Manufacturer Date | 2002-03-01 |
| Date Added to Maude | 2003-03-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DAVID CROMWICK |
| Manufacturer Street | 411 WAVERLEY OAKS ROAD BLDG. 2 |
| Manufacturer City | WALTHAM MA 02452 |
| Manufacturer Country | US |
| Manufacturer Postal | 02452 |
| Manufacturer Phone | 7819067916 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-3000 MICROKERATOME BLADE |
| Generic Name | MICROKERATOME BLADE |
| Product Code | HMY |
| Date Received | 2003-03-12 |
| Returned To Mfg | 2003-01-14 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 378607 |
| ID Number | M22076-959 |
| Device Expiration Date | 2005-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 437450 |
| Manufacturer | BD OPHTHALMIC SYSTEMS |
| Manufacturer Address | 264 QUARRY RD. MILFORD CT 06460 US |
| Baseline Brand Name | K-3000 MICROKERATOME BLADE |
| Baseline Generic Name | MICROKERATOME BLADE |
| Baseline Model No | * |
| Baseline Catalog No | * |
| Baseline ID | M22076-959 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-03-12 |