MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-08-08 for PLEURAFLOW SYSTEM WITH FLOWGLIDE PFFG-32 manufactured by Clearflow Inc.
| Report Number | 3008782989-2019-00001 |
| MDR Report Key | 8875275 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-08-08 |
| Date of Report | 2019-08-08 |
| Date Mfgr Received | 2019-07-16 |
| Date Added to Maude | 2019-08-08 |
| 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 | DR DOV GAL |
| Manufacturer Street | 1630 S. SUNKIST ST. SUITE E |
| Manufacturer City | ANAHEIM CA 92806 |
| Manufacturer Country | US |
| Manufacturer Postal | 92806 |
| Manufacturer Phone | 7149165014 |
| Manufacturer G1 | XERIDIEM MEDICAL DEVICES |
| Manufacturer Street | 4700 SOUTH OVERLAND DR. |
| Manufacturer City | TUCSON AZ 85714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLEURAFLOW SYSTEM WITH FLOWGLIDE |
| Generic Name | PLEURAFLOW SYSTEM WITH FLOWGLIDE |
| Product Code | OTK |
| Date Received | 2019-08-08 |
| Model Number | PFFG-32 |
| Catalog Number | PFFG-32 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLEARFLOW INC |
| Manufacturer Address | 1630 S. SUNKIST ST. SUITE E ANAHEIM CA 93806 US 93806 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-08-08 |