MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-07 for LIQUICHEK URINALYSIS CONTROL 437 manufactured by Bio-rad Laboratories.
[37107172]
Technical services received the initial report and explained to the lab professional she should follow her lab's procedure for injury and potential hazardous materials exposure.
Patient Sequence No: 1, Text Type: N, H10
[37107173]
A lab professional splashed level 2, urinalysis control in her right eye on (b)(6) 2004 at 3 a. M.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016706-2004-00001 |
| MDR Report Key | 5353669 |
| Date Received | 2004-09-07 |
| Date of Report | 2004-08-17 |
| Date of Event | 2004-08-12 |
| Date Mfgr Received | 2004-08-12 |
| Device Manufacturer Date | 2003-08-01 |
| Date Added to Maude | 2016-01-08 |
| 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 | 3 |
| Manufacturer Contact | LOURDES BERNAL, RA REP |
| Manufacturer Street | 9500 JERONIMO RD. |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9495981338 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIQUICHEK URINALYSIS CONTROL |
| Generic Name | QUALITY CONTROL MATERIAL |
| Product Code | JJW |
| Date Received | 2004-09-07 |
| Model Number | NA |
| Catalog Number | 437 |
| Lot Number | 61202 |
| ID Number | NA |
| Device Expiration Date | 2006-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES |
| Manufacturer Address | 9500 JERONIMO RD. IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-09-07 |