MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-08-30 for IMMUNOPREPTM REAGENT A 300 TEST 7546999 manufactured by Beckman Coulter Inc..
[20952221]
A customer contacted beckman coulter inc. (bec) reporting that when the order of immunoprep reagent a was received, the reagent bottle had leaked (immunoprep reagent a is a colorless, clear, odorless, nonflammable acqueous solution. Exposure may result in irritation of skin, eyes and mucous membranes). No injury or exposure was reported and medical attention was not sought.
Patient Sequence No: 1, Text Type: D, B5
[21232452]
The defective immunoprep reagent kit was replaced. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1061932-2011-01293 |
| MDR Report Key | 2228050 |
| Report Source | 06 |
| Date Received | 2011-08-30 |
| Date of Report | 2011-07-25 |
| Date of Event | 2011-07-25 |
| Date Mfgr Received | 2011-07-25 |
| Device Manufacturer Date | 2011-05-18 |
| Date Added to Maude | 2012-06-22 |
| 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 | 0 |
| 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 | 11800 SW 147TH AVENUE, |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33196 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMUNOPREPTM REAGENT A 300 TEST |
| Generic Name | RED-CELL LYSING PRODUCT |
| Product Code | GGK |
| Date Received | 2011-08-30 |
| Model Number | NA |
| Catalog Number | 7546999 |
| Lot Number | 1099054K |
| ID Number | NI |
| Device Expiration Date | 2012-08-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-08-30 |