MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-16 for LIQUICHEK UNASSAYED CHEMISTRY CONTROL, LEVEL 1 691 manufactured by Bio-rad Laboratories, Inc..
[90435516]
Bio-rad shipping boxes were labeled as required by the united states (b)(4) for dry ice using a "miscellaneous" hazard symbol, class 9.
Patient Sequence No: 1, Text Type: N, H10
[90435517]
A customer reported receiving several boxes of bio-rad controls, packed with dry ice. The shipping boxes were placed into the walk-in refrigerator. The next day two employees walked into the refrigerator and reported to their supervisor that they experienced a "feeling of suffocation and/or throat and chest irritation and dry mouth. " both employees were sent to the emergency department where they were examined by a toxicologist md. They received an ekg, physical examinations, and their vitals were monitored. They were sent home. No hospitalization was required and no further treatment was received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016706-2017-00001 |
| MDR Report Key | 6953476 |
| Date Received | 2017-10-16 |
| Date of Report | 2017-10-16 |
| Date of Event | 2017-09-21 |
| Date Mfgr Received | 2017-09-22 |
| Device Manufacturer Date | 2016-06-30 |
| Date Added to Maude | 2017-10-16 |
| 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 | MS SUZANNE PARSONS |
| Manufacturer Street | 9500 JERONIMO ROAD |
| Manufacturer City | IRVINE CA 926182017 |
| Manufacturer Country | US |
| Manufacturer Postal | 926182017 |
| Manufacturer Phone | 9495981467 |
| Manufacturer G1 | BIO-RAD LABORATORIES, INC. |
| 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 | 0 |
| Brand Name | LIQUICHEK UNASSAYED CHEMISTRY CONTROL, LEVEL 1 |
| Generic Name | MULTI-ANALYTE CONTROLS UNASSAYED |
| Product Code | OHQ |
| Date Received | 2017-10-16 |
| Catalog Number | 691 |
| Lot Number | 31831 |
| Device Expiration Date | 2018-06-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES, INC. |
| Manufacturer Address | 9500 JERONIMO RD. IRVINE CA 926182017 US 926182017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-16 |