MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-10-23 for LIQUICHEK SEDIMENTATION RATE CONTROL 514 manufactured by Bio-rad, Diagnostics Grp..
[4983659]
In (b)(6), a laboratory technologist cut her index finer on a becton-dickinson sedimentation tube containing liquichek sedimentation rate control while applying pressure to a stopper on the tube. The laboratory technologist sought medical treatment and was given (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[12389699]
The labeling and certificate of analysis of liquichek sedimentation rate control indicates that each human donor unit used to manufacture the product was tested by fda accepted methods and found (b)(6). In addition, the labeling instructs the user to treat all human source material as potentially infection and should be handled with the same precautions used with patient specimens.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016706-2014-00002 |
| MDR Report Key | 4203434 |
| Report Source | 07 |
| Date Received | 2014-10-23 |
| Date of Report | 2014-10-22 |
| Date of Event | 2014-09-24 |
| Date Mfgr Received | 2014-09-24 |
| Device Manufacturer Date | 2014-06-01 |
| Date Added to Maude | 2014-10-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELIZABETH PLATT |
| Manufacturer Street | 9500 JERONIMO RD. |
| Manufacturer City | IRVINE CA 926182017 |
| Manufacturer Country | US |
| Manufacturer Postal | 926182017 |
| Manufacturer Phone | 9495981258 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIQUICHEK SEDIMENTATION RATE CONTROL |
| Generic Name | QUALITY CONTROL MATERIAL |
| Product Code | JJY |
| Date Received | 2014-10-23 |
| Model Number | NA |
| Catalog Number | 514 |
| Lot Number | 15841 |
| Device Expiration Date | 2014-12-04 |
| 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, DIAGNOSTICS GRP. |
| Manufacturer Address | 9500 JERONIMO RD. IRVINE CA 92618201 US 92618 2017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-23 |