MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-09 for OPTIGUIDE FIBER OPTIC DIFFUSER, DCYL SERIES DCYL200 DCYL250 manufactured by Pinnacle Biologics, Inc..
| Report Number | 3010119152-2019-00001 |
| MDR Report Key | 8772066 |
| Date Received | 2019-07-09 |
| Date of Report | 2019-08-06 |
| Date of Event | 2019-06-13 |
| Date Mfgr Received | 2019-06-13 |
| Device Manufacturer Date | 2017-06-20 |
| Date Added to Maude | 2019-07-09 |
| 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 Street | 2801 LAKESIDE DR., SUITE 210 |
| Manufacturer City | BANNOCKBURN IL 60015 |
| Manufacturer Country | US |
| Manufacturer Postal | 60015 |
| Manufacturer Phone | 8472837902 |
| Manufacturer G1 | PIONEER OPTICS CO. |
| Manufacturer Street | 35 GRIFFIN RD. SOUTH |
| Manufacturer City | BLOOMFIELD CT 06002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OPTIGUIDE FIBER OPTIC DIFFUSER, DCYL SERIES |
| Generic Name | FIBER OPTIC DIFFUSER |
| Product Code | MVG |
| Date Received | 2019-07-09 |
| Model Number | DCYL200 |
| Catalog Number | DCYL250 |
| Lot Number | 5844401 |
| Device Expiration Date | 2019-06-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2019-07-09 |