MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2011-04-15 for URIC ACID REAGENT 442785 manufactured by Beckman Coulter Inc..
[20411047]
Beckman coulter inc. , (bci) warehouse in taiwan reported that they received uric acid reagent and found that there are two bottles were leaking due to the breakage. No injury was reported on this issue.
Patient Sequence No: 1, Text Type: D, B5
[20590941]
No additional information regarding this event was supplied. Note: since the 510k field is limited to a single 510k number, the full 510k information for this product is provided below: k883181/k970919.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2011-00915 |
| MDR Report Key | 2060276 |
| Report Source | 01,08 |
| Date Received | 2011-04-15 |
| Date of Report | 2011-03-16 |
| Date of Event | 2011-03-16 |
| Date Mfgr Received | 2011-03-16 |
| Device Manufacturer Date | 2010-12-06 |
| Date Added to Maude | 2011-04-21 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NORA ZEROUNIAN |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149613634 |
| Manufacturer G1 | BECKMAN COULTER INC. |
| Manufacturer Street | 250 S. KRAEMER BLVD. |
| Manufacturer City | BREA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92821 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URIC ACID REAGENT |
| Generic Name | URIC ACID REAGENT |
| Product Code | KNK |
| Date Received | 2011-04-15 |
| Model Number | NA |
| Catalog Number | 442785 |
| Lot Number | M012242 |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER INC. |
| Manufacturer Address | 250 S KRAEMER BLVD. BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-15 |