MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-02-01 for COULTER TRUCOLOR WRIGHT GIEMSA STAIN A50832 manufactured by Beckman Coulter, Inc..
[16922367]
Beckman coulter, inc. (bec) personnel reported that four bottles of coulter trucolor wright-giemsa stain were found to be leaking a small amount of stain around the caps upon arrival at the lab. There was no report of patient results affected. There was no report of any adverse event or injury requiring medical intervention or patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[16936764]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2012-00207 |
| MDR Report Key | 2434606 |
| Report Source | 07 |
| Date Received | 2012-02-01 |
| Date of Report | 2012-01-05 |
| Date of Event | 2012-01-05 |
| Date Mfgr Received | 2012-01-05 |
| Device Manufacturer Date | 2011-10-05 |
| Date Added to Maude | 2012-08-10 |
| 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. DUNG NGUYEN |
| 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 | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COULTER TRUCOLOR WRIGHT GIEMSA STAIN |
| Generic Name | STAINS, HEMATOLOGY |
| Product Code | KQC |
| Date Received | 2012-02-01 |
| Catalog Number | A50832 |
| Lot Number | 0633783 |
| Device Expiration Date | 2013-04-05 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER, INC. |
| Manufacturer Address | 11800 SW 147TH AVENUE MIAMI FL 33196 US 33196 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-01 |