MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-23 for PERMOBIL M3 N/A manufactured by Permobil Inc..
Report Number | 1221084-2020-00016 |
MDR Report Key | 9868241 |
Report Source | CONSUMER |
Date Received | 2020-03-23 |
Date of Report | 2020-03-23 |
Date of Event | 2020-02-22 |
Date Mfgr Received | 2020-02-25 |
Device Manufacturer Date | 2019-12-27 |
Date Added to Maude | 2020-03-23 |
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. KEVIN BULLOCK |
Manufacturer Street | 300 DUKE DRIVE |
Manufacturer City | LEBANON, TN |
Manufacturer Country | US |
Manufacturer Phone | 7360925451 |
Manufacturer G1 | PERMOBIL INC. |
Manufacturer Street | 300 DUKE DRIVE |
Manufacturer City | LEBANON, TN |
Manufacturer Country | US |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | PERMOBIL M3 |
Generic Name | POWERED WHEELCHAIR |
Product Code | ITI |
Date Received | 2020-03-23 |
Model Number | M3 |
Catalog Number | N/A |
Lot Number | N/A |
Operator | LAY USER/PATIENT |
Device Availability | Y |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | PERMOBIL INC. |
Manufacturer Address | 300 DUKE DRIVE LEBANON, TN US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-23 |