MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2001-07-18 for K-3000 MICROKERATOME BLADES 378607 manufactured by Bd Ophthalmic Systems.
[244704]
Customers reported that: the blade assemblies were difficult to insert into the keratome head. The blade assemblies at times failed to oscillate properly, and may have resulted in an undesirable surgical outcome. Most difficulties were experienced during the blade test phase (not on pt).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226073-2001-00003 |
| MDR Report Key | 343194 |
| Report Source | 01 |
| Date Received | 2001-07-18 |
| Report Date | 2001-07-17 |
| Date Mfgr Received | 2001-06-26 |
| Device Manufacturer Date | 2001-03-01 |
| Date Added to Maude | 2001-07-25 |
| 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 | PAT FILOSA |
| Manufacturer Street | 411 WAVERLEY OAKS ROAD BLDG. 2, SUITE 229 |
| Manufacturer City | WALTHAM MA 02452 |
| Manufacturer Country | US |
| Manufacturer Postal | 02452 |
| Manufacturer Phone | 7819067917 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-3000 MICROKERATOME BLADES |
| Generic Name | KERATOME BLADES |
| Product Code | HMY |
| Date Received | 2001-07-18 |
| Model Number | NA |
| Catalog Number | 378607 |
| Lot Number | M-20219-00859 |
| ID Number | NA |
| Device Expiration Date | 2004-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 332533 |
| 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 Catalog No | 378607 |
| Baseline Device Family | BD K-3000 MICROKERATOME SYSTEM & ACCESSORIES |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K984537 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-07-18 |