MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-17 for PERMOBIL F3 N/A manufactured by Permobil Inc..
[184112858]
Reports provided to permobil claim the end-user was driving their device at full speed when they inadvertently contacted an immoveable object with the joystick. Reports claim the impact was strong enough to significantly damage the joystick, rendering the device inoperable. Reports indicate the end-user was taken to the hospital with undisclosed injuries. Further attempts to gain information as to extent of injury have been unsuccessful with latest reports indicating the end-user being transferred into a skilled facility for the interim. Service provider reports being informed by staff members of the assisted living facility of the event being caused by the end-user in their failure to reduce speed when negotiating a narrow area. There were no allegations or claims made indicating the device malfunctioned or deviated in any way to have contributed to this event. Review of the dhr shows the device met specification prior to distribution.
Patient Sequence No: 1, Text Type: N, H10
[184112859]
Received report stating as end-user was driving at full speed, they inadvertently collided with an object impacting the joystick control. This impact reportedly caused an unspecified injury to the end-user requiring medical intervention and hospitalization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221084-2020-00009 |
| MDR Report Key | 9717758 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-17 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2016-10-19 |
| Date Added to Maude | 2020-02-17 |
| 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 F3 |
| Generic Name | POWERED WHEELCHAIR |
| Product Code | ITI |
| Date Received | 2020-02-17 |
| Model Number | F3 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Hospitalization | 2020-02-17 |