MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-28 for ACESSA SYSTEM manufactured by Acessa Health Inc..
| Report Number | 3006443171-2019-00002 |
| MDR Report Key | 8746538 |
| Date Received | 2019-06-28 |
| Date of Report | 2019-06-28 |
| Date of Event | 2019-05-28 |
| Date Mfgr Received | 2019-05-30 |
| Date Added to Maude | 2019-06-28 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ISAAC RODRIGUEZ |
| Manufacturer Street | 7004 BEE CAVE RD. BLDG. 3, STE. 200 |
| Manufacturer City | AUSTIN TX 78746 |
| Manufacturer Country | US |
| Manufacturer Postal | 78746 |
| Manufacturer Phone | 5127850707 |
| Manufacturer G1 | ACESSA HEALTH INC. |
| Manufacturer Street | 7004 BEE CAVE RD. BLDG. 3, STE. 200 |
| Manufacturer City | AUSTIN TX 78746 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78746 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ACESSA SYSTEM |
| Generic Name | ACESSA |
| Product Code | HFG |
| Date Received | 2019-06-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACESSA HEALTH INC. |
| Manufacturer Address | 7004 BEE CAVE RD. BDG. 3, STE. 200 AUSTIN TX 78746 US 78746 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2019-06-28 |