MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-20 for LIQUICHEK TUMOR MARKER CONTROL manufactured by Bio-rad Laboratories.
[129321897]
On (b)(6) 2018, bio-rad qsd technical support received a call from bio-rad (b)(4) reporting a potential adverse event. Dr. (b)(6) at hospital (b)(6) reported that mrs. (b)(6), a laboratory technician dropped liquichek tumor marker control lot #23951 on the floor and it splashed into her eye.
Patient Sequence No: 1, Text Type: N, H10
[129321898]
On (b)(6) 2018, bio-rad qsd technical support received a call from bio-rad (b)(4) reporting a potential adverse event. Dr. (b)(6) at hospital (b)(6) reported that mrs. (b)(6), a laboratory technician dropped liquichek tumor marker control lot #23951 on the floor and it splashed into her eye.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016706-2018-00006 |
| MDR Report Key | 8089923 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-20 |
| Date of Report | 2018-11-19 |
| Date of Event | 2018-10-31 |
| Date Mfgr Received | 2018-10-31 |
| Date Added to Maude | 2018-11-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS AZAR KHATIBI |
| Manufacturer Street | 9500 JERONIMO ROAD |
| Manufacturer City | IRVINE CA 926182017 |
| Manufacturer Country | US |
| Manufacturer Postal | 926182017 |
| Manufacturer Phone | 9495981210 |
| Manufacturer G1 | BIO-RAD LABORATORIES |
| Manufacturer Street | 9500 JERONIMO ROAD |
| Manufacturer City | IRVINE CA 926182017 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 926182017 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIQUICHEK TUMOR MARKER CONTROL |
| Generic Name | MULTI-ANALYTE CONTROL, ALL KINDS (ASSAYED ) JJY |
| Product Code | JJY |
| Date Received | 2018-11-20 |
| Lot Number | 23591 |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES |
| Manufacturer Address | 9500 JERONIMO ROAD IRVINE CA 926182017 US 926182017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-20 |