MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2001-11-28 for LIQUICHEK CK/LD ISOENZYME CONTROL * 672 manufactured by Bio-rad Laboratories.
[212405]
A customer splashed level 2 control material into customer's eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016706-2001-00005 |
| MDR Report Key | 363636 |
| Report Source | 01,07 |
| Date Received | 2001-11-28 |
| Date of Report | 2001-11-16 |
| Date Mfgr Received | 2001-10-31 |
| Device Manufacturer Date | 1999-05-01 |
| Date Added to Maude | 2001-12-06 |
| 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 LLOYD |
| Manufacturer Street | 9500 JERONIMO ROAD |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9495981465 |
| 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 | LIQUICHEK CK/LD ISOENZYME CONTROL |
| Generic Name | QUALITY CONTROL REAGENT |
| Product Code | JJT |
| Date Received | 2001-11-28 |
| Model Number | * |
| Catalog Number | 672 |
| Lot Number | 30082 |
| ID Number | * |
| Device Expiration Date | 2001-05-31 |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 352744 |
| Manufacturer | BIO-RAD LABORATORIES |
| Manufacturer Address | 9500 JERONIMO RD. IRVINE CA 92683 US |
| Baseline Brand Name | LIQUICHEK CK/LD ISOENZYME CONTROL |
| Baseline Generic Name | QUALITY CONTROL REAGENT |
| Baseline Model No | * |
| Baseline Catalog No | 672 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-11-28 |