MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-14 for PERMOBIL M300 N/A manufactured by Permobil Inc..
[184112527]
Reports provided claim as the end-user was operating the power leg function of the seating, at one point they felt the footplate lift up, presumably from contacting the caster. This action caused the end-user to panic and for reasons they could not explain, grabbed the joystick knob and accelerated forward. When doing this, they continued to drive until colliding with the edge of a transfer board. This collision impacted their leg, reportedly inducing a laceration to their left calf requiring medical intervention. End-user reported being hospitalized for 5 weeks, requiring staples and skin grafts. Service provider reports having inspected the device and found it to be fully operational with no mechanical issues being noted. The end-user fully admitted the accident was their fault as they panicked. End-user reported they were not driving the chair when the footplate allegedly contacted the footplate, only after feeling their foot move upward did they have the urge of panic and thus drove the device. No allegations were made that the device operated abnormally to have caused this event. The dhr was reviewed and device met specification prior to distribution.
Patient Sequence No: 1, Text Type: N, H10
[184112528]
Received report claiming as end-user was operating seat functions, one of the footplates contacted a caster wheel which caused the end-user to panic. Reports indicate while in their panicked state, they grabbed the joystick and drove forward until the device collided into an unspecified object. Reports claim the end-user suffered serious injuries requiring medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221084-2020-00008 |
| MDR Report Key | 9711470 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-14 |
| Date of Event | 2019-11-15 |
| Date Mfgr Received | 2020-01-24 |
| Device Manufacturer Date | 2017-02-28 |
| Date Added to Maude | 2020-02-14 |
| 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 DR. |
| Manufacturer City | LEBANON, TN |
| Manufacturer Country | US |
| Manufacturer Phone | 7360925451 |
| Manufacturer G1 | PERMOBIL INC. |
| Manufacturer Street | 300 DUKE DR. |
| Manufacturer City | LEBANON, TN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERMOBIL M300 |
| Generic Name | POWER WHEELCHAIR |
| Product Code | ITI |
| Date Received | 2020-02-14 |
| Model Number | M300 |
| 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 DR. LEBANON, TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-02-14 |