MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-28 for OPTIGUIDE FIBER OPTIC DIFFUSER PB250 manufactured by Pinnacle Biologics, Inc..
| Report Number | 3010119152-2020-00001 |
| MDR Report Key | 9769529 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-29 |
| Date Added to Maude | 2020-02-28 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 2801 LAKESIDE DR., SUITE 210 |
| Manufacturer City | BANNOCKBURN 60015 |
| Manufacturer Country | US |
| Manufacturer Postal | 60015 |
| Manufacturer Phone | 8472837902 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIGUIDE FIBER OPTIC DIFFUSER |
| Generic Name | FIBER OPTIC DIFFUSER |
| Product Code | MVG |
| Date Received | 2020-02-28 |
| Model Number | PB250 |
| Lot Number | DG19048 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PINNACLE BIOLOGICS, INC. |
| Manufacturer Address | 2801 LAKESIDE DR., SUITE 210 BANNOCKBURN IL 60015 US 60015 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-28 |