MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-13 for PERMOBIL F5 N/A manufactured by Permobil Inc..
[184112059]
Reports provided by the end-users family member claim as the end-user was upstairs on the second story of their home, they maneuvered their device too close to the stairwell entrance which allowed one of the wheels to drop off the edge of the upper step. This resulted in the device becoming unstable and falling approximately 15 steps to the bottom landing. Reports indicate the end-user was admitted to the hospital having received multiple broken bones, but the specifics and extent of injuries were not provided. The service provider reports the device remains fully operational in both seat functions and drive maneuverability, having sustained relatively minor damages as a result of the fall. Provider reports interviews with the end-user and family indicate this event was a judgement error by the end-user and no allegations or claims were made of a device malfunction or error having contributed to this event. The dhr was reviewed and device met specification prior to distribution.
Patient Sequence No: 1, Text Type: N, H10
[184112060]
Received report claiming end-user having inadvertently maneuvered their device over the top edge of a stairwell falling approximately 15 steps to the bottom. End-user reported to have suffered significant injuries requiring medical attention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221084-2020-00007 |
| MDR Report Key | 9708586 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-01-12 |
| Date Mfgr Received | 2020-01-16 |
| Device Manufacturer Date | 2018-04-12 |
| Date Added to Maude | 2020-02-13 |
| 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 F5 |
| Generic Name | POWERED WHEELCHAIR |
| Product Code | ITI |
| Date Received | 2020-02-13 |
| Model Number | F5 |
| 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 | 1. Hospitalization | 2020-02-13 |