MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-08-26 for INNERVISION TRANSILLUMINATION SYSTEM 1465-50 manufactured by Diversatek Healthcare.
| Report Number | 2183446-2019-00001 |
| MDR Report Key | 8932030 |
| Report Source | OTHER |
| Date Received | 2019-08-26 |
| Date of Report | 2019-08-19 |
| Date of Event | 2019-04-19 |
| Date Mfgr Received | 2019-07-02 |
| Device Manufacturer Date | 2018-09-12 |
| Date Added to Maude | 2019-08-26 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAURA BOLL |
| Manufacturer Street | 102 E KEEFE AVE |
| Manufacturer City | MILWAUKEE WI 53212 |
| Manufacturer Country | US |
| Manufacturer Postal | 53212 |
| Manufacturer Phone | 4142657620 |
| Manufacturer G1 | DIVERSATEK HEALTHCARE |
| Manufacturer Street | 102 E KEEFE AVE |
| Manufacturer City | MILWAUKEE WI 53212 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INNERVISION TRANSILLUMINATION SYSTEM |
| Generic Name | LIGHTED BOUGIE |
| Product Code | FDG |
| Date Received | 2019-08-26 |
| Model Number | 1465-50 |
| Catalog Number | 1465-50 |
| Lot Number | 222549 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIVERSATEK HEALTHCARE |
| Manufacturer Address | 102 E KEEFE AVE MILWAUKEE WI 53212 US 53212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-08-26 |