MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-15 for KALLSTEAD HEP-2 AND ANCA N/A 29403, 32583 manufactured by Bio-rad Laboratories, Inc..
[127347760]
Customer is a nurse. When opening the fridge, anca or hep-2 slides fell (about 4 to 5 slides). Attempting to pick up the broken slides the customer cut herself although she was wearing protective gloves. The customer washed her hands thoroughly with soap and left her finger in the alcohol for about 40 minutes. A serology check will be done in 7 weeks. The customer went to see a doctor. The doctor has assured the customer that there is no hiv risk , because the slides were old and dated as of 2012. Customer was injured on (b)(6) 2018. (b)(6) customer rep (b)(6) will contact customer for followup information in 7 weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000135116-2018-00001 |
| MDR Report Key | 8075780 |
| Date Received | 2018-11-15 |
| Date of Report | 2018-11-15 |
| Date of Event | 2018-11-07 |
| Date Mfgr Received | 2018-11-08 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2018-11-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NGHIA LUU |
| Manufacturer Street | 5500 EAST SECOND STREET |
| Manufacturer City | BENICIA, |
| Manufacturer G1 | IMMCO DIAGNOSTIC, INC |
| Manufacturer Street | 60 PINEVIEW DR |
| Manufacturer City | AMHERST NY 14228 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14228 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KALLSTEAD HEP-2 AND ANCA |
| Generic Name | ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL |
| Product Code | DBM |
| Date Received | 2018-11-15 |
| Model Number | N/A |
| Catalog Number | 29403, 32583 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES, INC. |
| Manufacturer Address | 5500 EAST SECOND STREET BENICIA CA 94510 US 94510 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-15 |