MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-02-26 for KATENA K3-2398 manufactured by .
[8251398]
Upon receipt of med-watch report from fda - mfr contacted user facility to inquire of reported event. Verbally confirmed from user facility risk management department personnel that "no injury to pt was reported by the doctor. " also confirmed that the device would be available for mfr assessment in approx 2-4 weeks. As of the date of this report, the device is reportedly going to be returned for mfr eval but, has not been received. Based on this, the subject device has not be evaluated by the mfr. If subject device is made available to mfg, a follow-up med-watch report will be filed with any eval results. Review of mfr complaint handling system database confirms this is the first report of this nature for this device (k3-2398). Device has been in commercial distribution since 12/1994. Examination of a representative sample found no abnormalities that could cause to product failure during intended use and handling scenarios.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242450-2009-00001 |
| MDR Report Key | 1344489 |
| Report Source | 00 |
| Date Received | 2009-02-26 |
| Date Mfgr Received | 2009-01-29 |
| Date Added to Maude | 2009-03-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 4 STEWART CT |
| Manufacturer City | DENVILLE NJ 07834 |
| Manufacturer Country | US |
| Manufacturer Postal | 07834 |
| Manufacturer Phone | 9739891600 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KATENA |
| Generic Name | ROWEN PHACO SPATULA, DOUBLE-ENDED |
| Product Code | HND |
| Date Received | 2009-02-26 |
| Catalog Number | K3-2398 |
| Lot Number | NA |
| ID Number | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-26 |