MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-27 for ARROW SUPER ARROW FLEX 7 FR INTRODUCER SHEATH CP-07711 manufactured by Teleflex.
| Report Number | 3012279212-2020-00002 |
| MDR Report Key | 9892162 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-27 |
| 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 Contact | BRIAN YOUNG |
| Manufacturer Street | 229 N MAIN STREET |
| Manufacturer City | BOERNE, TX |
| Manufacturer Country | US |
| Manufacturer Phone | 3400116 |
| Manufacturer G1 | PRYTIME MEDICAL DEVICES, INC. |
| Manufacturer Street | 229 NORTH MAIN STREET |
| Manufacturer City | BOERNE, TX |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW SUPER ARROW FLEX 7 FR INTRODUCER SHEATH |
| Generic Name | INTRODUCER, CATHETER |
| Product Code | DYB |
| Date Received | 2020-03-27 |
| Model Number | CP-07711 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |