MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-07-07 for AXSYM REA ETHANOL REAGENT 3B32-20 manufactured by Abbott Health Products, Inc..
[390231]
The customer states th at their lab used syringes to aspirate abbott ethanol controls from their vials and dispense the solution into sample cups for analysis. While dispensing control into a sample cup, the customer stuck their thrumb with the syringe. The abbott customer technical advocate faxed a msds to the customer. The customer is being tested for hiv, hcv and hepatitis b and received a tetanus shot. There is no impact to pt management reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2623532-2005-00002 |
| MDR Report Key | 619727 |
| Report Source | 05,06 |
| Date Received | 2005-07-07 |
| Date of Report | 2005-07-07 |
| Date of Event | 2005-06-08 |
| Date Mfgr Received | 2005-06-08 |
| Date Added to Maude | 2005-07-08 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR DAVID SPINDELL |
| Manufacturer Street | 100 ABBOTT PARK RD D-09Y6, AP6C-2 |
| Manufacturer City | ABBOTT PARK IL 600646092 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646092 |
| Manufacturer Phone | 8479351869 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXSYM REA ETHANOL REAGENT |
| Generic Name | QUANTITATIVE REA FOR THE MEASUREMENT OF ALCOH |
| Product Code | DML |
| Date Received | 2005-07-07 |
| Model Number | NA |
| Catalog Number | 3B32-20 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 609415 |
| Manufacturer | ABBOTT HEALTH PRODUCTS, INC. |
| Manufacturer Address | KM 58.0, CARRETERA 2 CRUCE DAVILA BARCELONETA PR 00617 US |
| Baseline Brand Name | AXSYM REA ETHANOL REAGENT |
| Baseline Generic Name | QUANTITATIVE REA FOR THE MEASUREMENT OF ALCOHOL |
| Baseline Model No | NA |
| Baseline Catalog No | 3B32-20 |
| Baseline ID | NA |
| Baseline Device Family | AXSYM REA ETHANOL ASSAY |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K953765 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-07-07 |