MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-30 for ER-REBOA CATHETER ER7232A manufactured by Prytime Medical Devices, Inc..
| Report Number | 3012279212-2020-00004 |
| MDR Report Key | 9896320 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-29 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-30 |
| 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 NORTH 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 | ER-REBOA CATHETER |
| Generic Name | CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY |
| Product Code | MJN |
| Date Received | 2020-03-30 |
| Model Number | ER-REBOA |
| Catalog Number | ER7232A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRYTIME MEDICAL DEVICES, INC. |
| Manufacturer Address | 229 NORTH MAIN STREET BOERNE, TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |