MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-08-10 for ACS:180 SE * manufactured by Kmc Systems Inc,.
[16279522]
In july 2005 a healthcare professional at a medical center reported that on the previous day an operator of an acs:180 analyzer scraped their hand with the instruments sample probe. The operator washed the site of the injury, applied a disinfectant and bandaged it. The operator received the scratch while trying to replace the sample probe on the instrument due to a clog in the probe, all indications are that the operator followed instructions and was using proper protective equipment at the time of the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2005-00011 |
| MDR Report Key | 625736 |
| Report Source | 05,06 |
| Date Received | 2005-08-10 |
| Date of Report | 2005-07-14 |
| Date of Event | 2005-07-13 |
| Date Mfgr Received | 2005-07-14 |
| Device Manufacturer Date | 2003-02-01 |
| Date Added to Maude | 2005-08-15 |
| 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 | ANDRES HOLLE |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243494 |
| Manufacturer G1 | KMC SYSTEMS INC. |
| Manufacturer Street | * |
| Manufacturer City | MERRIMACK NH * |
| Manufacturer Country | US |
| Manufacturer Postal Code | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACS:180 SE |
| Generic Name | IMMUNOASSAY SYSTEM |
| Product Code | LCI |
| Date Received | 2005-08-10 |
| Model Number | ACS:180 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 615364 |
| Manufacturer | KMC SYSTEMS INC, |
| Manufacturer Address | * MERRIMACK NH * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-08-10 |