MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-10-06 for LIQUICHECK IMMUNOASSAY PLUS CONTROL 363 manufactured by Bio-rad Laboratories.
[304032]
A lab employee cut their finger on a medical crimp seal while opening a bottle of quality control.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016706-2003-00003 |
| MDR Report Key | 488332 |
| Report Source | 05 |
| Date Received | 2003-10-06 |
| Date of Report | 2003-09-30 |
| Date of Event | 2003-09-21 |
| Date Mfgr Received | 2003-09-23 |
| Device Manufacturer Date | 2001-12-01 |
| Date Added to Maude | 2003-10-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | YVETTE LOYD SENIOR SPECIALIST |
| Manufacturer Street | 9500 JERONIMO RD |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9495981200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIQUICHECK IMMUNOASSAY PLUS CONTROL |
| Generic Name | QUALITY CONTROL MATERIAL |
| Product Code | JJT |
| Date Received | 2003-10-06 |
| Model Number | NA |
| Catalog Number | 363 |
| Lot Number | 40613 |
| ID Number | NA |
| Device Expiration Date | 2004-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 477177 |
| Manufacturer | BIO-RAD LABORATORIES |
| Manufacturer Address | 9500 JERONIMO RD. IRVINE CA 92618 US |
| Baseline Brand Name | LIQUICHECK IMMUNOASSAY PLUS CONTROL |
| Baseline Generic Name | QUALITY CONTROL MATERIAL |
| Baseline Model No | NA |
| Baseline Catalog No | 363 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-10-06 |