MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-06-28 for LIQUICHEK URINALYSIS CONTROL 437 manufactured by Bio-rad Laboratories.
[635250]
A laboratory technician cut her right index finger while capping a test tube that contained level 2 control material. The lab technician was wearing gloves at the time of the event and immediately washed her hands with soap and water and applied neosporin and a band-aid. The lab technician did not require any stitches or hospitalization; however, the lab technician reported the event to the hospital facility's occupational health department and received a tetanus. There was no immediate harm to the laboratory professional as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[7974445]
The labeling and certificate of analysis indicate that the serum from each donor contributing urine for this product was tested and found non-reactive at the donor level per current applicable fda requirements using fda accepted methods including testing for hiv-1/hiv-2 antibody, hbsag, hcv antibody, hiv-1 and hcv by a nucleic acid test (nat). In addition, the labeling instructs the users to treat all human source material as potentially infectious and should be handled with the same precautions used with patient specimens.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016706-2007-00002 |
| MDR Report Key | 873140 |
| Report Source | 07 |
| Date Received | 2007-06-28 |
| Date of Report | 2007-06-22 |
| Date of Event | 2007-06-10 |
| Date Mfgr Received | 2007-06-11 |
| Date Added to Maude | 2007-09-20 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LOURDES BERNAL, REP |
| Manufacturer Street | 9500 JERONIMO ROAD |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9495981338 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIQUICHEK URINALYSIS CONTROL |
| Generic Name | NONE |
| Product Code | JJW |
| Date Received | 2007-06-28 |
| Model Number | NA |
| Catalog Number | 437 |
| Lot Number | 61272 |
| ID Number | NA |
| Device Expiration Date | 2009-07-31 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 854897 |
| Manufacturer | BIO-RAD LABORATORIES |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-06-28 |