MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-11 for PROBASICS 9201 manufactured by .
Report Number | 3012316249-2019-00034 |
MDR Report Key | 9179388 |
Date Received | 2019-10-11 |
Date of Report | 2019-10-11 |
Date of Event | 2016-01-14 |
Date Facility Aware | 2019-08-22 |
Report Date | 2019-10-11 |
Date Reported to FDA | 2019-10-11 |
Date Added to Maude | 2019-10-11 |
Event Key | 0 |
Report Source Code | Distributor report |
Manufacturer Link | N |
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 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | PROBASICS |
Generic Name | TRANSPORT CHAIR |
Product Code | INM |
Date Received | 2019-10-11 |
Model Number | 9201 |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization | 2019-10-11 |