MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-06-10 for LEICA BIOSYSTEMS 38440502 manufactured by Leica Biosystems Richmond.
| Report Number | 1419341-2019-00002 |
| MDR Report Key | 8685216 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-06-10 |
| Date of Report | 2019-06-10 |
| Date of Event | 2019-03-18 |
| Date Mfgr Received | 2019-03-27 |
| Date Added to Maude | 2019-06-10 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PETER SPARACIO |
| Manufacturer Street | 5205 US HIGHWAY 12 |
| Manufacturer City | RICHMOND IL 60071 |
| Manufacturer Country | US |
| Manufacturer Postal | 60071 |
| Manufacturer Phone | 8156782000 |
| Manufacturer G1 | LEICABIOSYSTEMS RICHMOND |
| Manufacturer Street | 5205 US HIGHWAY 12 |
| Manufacturer City | RICHMOND IL 60071 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60071 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA BIOSYSTEMS |
| Generic Name | GREEN JET BIOPSY II TAPED CASSETTE WITH LID |
| Product Code | IDZ |
| Date Received | 2019-06-10 |
| Model Number | 38440502 |
| Lot Number | A22589993 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS RICHMOND |
| Manufacturer Address | 5205 US HIGHWAY 12 RICHMOND IL 60071 US 60071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-06-10 |