MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-05-20 for ICON MONO IMMUNOCHEMICAL ANTIGEN TEST 395100 manufactured by Beckman Coulter, Inc..
[867497]
A customer contacted beckman coulter inc. (bci) regarding an incident where the tech cut her hand with a broken capillary tube while working with pt samples on the icon mono kit. The tech was wearing gloves at the time of breakage. She did not need to seek medical attention. There is no reported effect to pt or user.
Patient Sequence No: 1, Text Type: D, B5
[8085704]
No other add'l info is available for this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916283-2008-00005 |
| MDR Report Key | 1048428 |
| Report Source | 99 |
| Date Received | 2008-05-20 |
| Date of Report | 2008-05-20 |
| Date of Event | 2008-04-28 |
| Date Mfgr Received | 2008-04-28 |
| Date Added to Maude | 2009-05-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NORA ZEROUNIAN, MGR-CORPORATE |
| Manufacturer Street | 200 S KRAEMER BLVD PO BOX 8000, MAIL STOP:W-110 |
| Manufacturer City | BREA CA 928228000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928228000 |
| Manufacturer Phone | 7149613634 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICON MONO IMMUNOCHEMICAL ANTIGEN TEST |
| Generic Name | QUALITATIVE ANTIGEN TEST |
| Product Code | KTN |
| Date Received | 2008-05-20 |
| Model Number | NA |
| Catalog Number | 395100 |
| Lot Number | 227L11 |
| ID Number | NA |
| Device Expiration Date | 2008-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 10 PAGE MILL RD PATO ALTO CA 94304 US 94304 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-05-20 |