MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-06 for VIROTROL I 00100E manufactured by Bio-rad Laboratories, Inc..
[99796008]
The labeling for virotrol indicates this product contains biological source material and should be treated as potentially infectious. Each human serum or plasma donor unit used in the preparation of this product was tested for the presence of hbsag, antibodies to hiv-1 and hiv-2 and antibodies to hcv using licensed reagents. Human source materials reactive for viral hepatitis markers and antibodies to retroviruses used to produce this product have been treated to inactivate infectious agents. However, no known test method can assure that products derived from human sources will not transmit infection. It is recommended that this product and all human specimens be handled in accordance with biosafety level 2 practices as described in (b)(4) and (b)(4), biosafety in microbiological and biomedical laboratories, or other equivalent guidelines.
Patient Sequence No: 1, Text Type: N, H10
[99796009]
On (b)(6) 2018 bio-rad qsd technical support received a report from (b)(6) reporting that a laboratory individual had splashed virotrol i control into her eye. The individual cleaned her eyes by splashing water. She also saw a doctor in the hospital and was tested for (b)(6) antibody. The incident occurred in the hospital lab.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016706-2018-00001 |
| MDR Report Key | 7246263 |
| Date Received | 2018-02-06 |
| Date of Report | 2018-02-06 |
| Date of Event | 2018-01-09 |
| Date Mfgr Received | 2018-01-10 |
| Device Manufacturer Date | 2016-11-30 |
| Date Added to Maude | 2018-02-06 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MARIA ZEBALLOS |
| Manufacturer Street | 9500 JERONIMO RD. |
| Manufacturer City | IRVINE CA 926182017 |
| Manufacturer Country | US |
| Manufacturer Postal | 926182017 |
| Manufacturer Phone | 9495981200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VIROTROL I |
| Generic Name | KIT, QUALITY CONTROL FOR BLOOD BANKING REAGENTS |
| Product Code | KSF |
| Date Received | 2018-02-06 |
| Catalog Number | 00100E |
| Lot Number | 119100 |
| Device Expiration Date | 2019-11-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-02-06 |