MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-11-27 for ACTIVEAID 285 manufactured by Activeaid, Llc.
| Report Number | 2126684-2019-00003 |
| MDR Report Key | 9384242 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-11-27 |
| Date of Report | 2019-11-01 |
| Date of Event | 2019-11-01 |
| Date Mfgr Received | 2019-11-01 |
| Device Manufacturer Date | 2019-09-04 |
| Date Added to Maude | 2019-11-27 |
| 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 | AMY CURTIS |
| Manufacturer Street | 101 ACTIVEAID RAOD |
| Manufacturer City | REDWOOD FALLS MN 56283 |
| Manufacturer Country | US |
| Manufacturer Postal | 56283 |
| Manufacturer Phone | 5076442951 |
| Manufacturer G1 | ACTIVEAID, LLC |
| Manufacturer Street | 101 ACTIVEAID ROAD |
| Manufacturer City | REDWOOD FALLS MN 56283 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 56283 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTIVEAID |
| Generic Name | 285 REHAB SHOWER/COMMODE CHAIR - TILT |
| Product Code | INN |
| Date Received | 2019-11-27 |
| Model Number | 285 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACTIVEAID, LLC |
| Manufacturer Address | 101 ACTIVEAID ROAD REDWOOD FALLS MN 56283 US 56283 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-27 |