MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-03 for BECKMAN CX AMMONIA/ALCOHOL CONTROL 465996 manufactured by Beckman Coulter Inc..
[2559716]
Customer called on (b)(6) 2012 reporting that one of her laboratory technicians cut his finger while attempting to open a bottle of beckman cx ammonia/alcohol control as he attempted to remove the metal seal from the bottle. Customer reported that the technician was not wearing gloves at the time of the incident. The technician did seek medical attention and was treated for a small laceration on his right thumb but did not require stitches. The technician also received a tetanus shot as prophylaxis for infection.
Patient Sequence No: 1, Text Type: D, B5
[9593229]
Evaluation - conclusion: the laceration was caused by the metal seal on the bottle.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2050012-2012-00387 |
| MDR Report Key | 2438681 |
| Report Source | 05,06 |
| Date Received | 2012-02-03 |
| Date of Report | 2012-01-05 |
| Date of Event | 2012-01-05 |
| Date Mfgr Received | 2012-01-05 |
| Date Added to Maude | 2012-08-13 |
| 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 BOULEVARD |
| Manufacturer City | BREA CA 92821 |
| Manufacturer Country | US |
| Manufacturer Postal | 92821 |
| Manufacturer Phone | 7149614941 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BECKMAN CX AMMONIA/ALCOHOL CONTROL |
| Generic Name | ALCOHOL CONTROL METERIALS |
| Product Code | DKC |
| Date Received | 2012-02-03 |
| Model Number | CX AMMONIA/ALCOHOL CONTROL |
| Catalog Number | 465996 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | * |
| 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 | 2012-02-03 |