MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2009-01-15 for ABBOTT M2000SP INSTRUMENT 9K14-01 manufactured by Abbott Molecular.
[15615974]
A lab tech may have been exposed to biohazard material while cleaning the m200sp instrument (b) (4) when his glove was torn. Specifically, a lab tech was cleaning the m2000sp and he grazed his gloved hand across the roma arm of the m2000sp instrument. The glove was torn and the graze bled slightly, minutes after the incident. A plaster (bandaid) was applied. Since the time of the incident, the graze has healed. There was no fever associated with this incident. The pt states that there are no plans to monitor him for (b) (6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005248192-2009-00001 |
| MDR Report Key | 1364018 |
| Report Source | 00,01,05 |
| Date Received | 2009-01-15 |
| Date of Report | 2008-12-22 |
| Date of Event | 2008-11-14 |
| Date Mfgr Received | 2008-12-22 |
| Date Added to Maude | 2009-12-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PAULA MARTIN |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617333 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT M2000SP INSTRUMENT |
| Generic Name | SAMPLE EXTRACTION DEVICE |
| Product Code | KEY |
| Date Received | 2009-01-15 |
| Model Number | 9K14-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR |
| Manufacturer Address | DES PLAINES IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-01-15 |