MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-12 for PERMOBIL F5 N/A manufactured by Permobil Ab (pab).
[184111616]
Reports received claim the end-user was attempting to reposition themselves deeper into the seating by use the elevating leg function in conjunction with leg length articulation. Reports indicate the end-user had incorporated the knee block assembly during this process in efforts to keep their legs in place and from bending at the knee during this operation. It was reported that during one of these operations the end-user suffered a fractured tibia, just below the patella, reportedly requiring the end-user to remain bedridden for approximately 1 month. The end-user and family members report this process of repositioning is the way the end-user had always done it in the past with their previous device. Reports indicate the end-user instructed his provider to adjust the knee block tension tighter to match their previous device in order to feel better supported. The users manual states that the knee block assembly should not to be used when solely operating the leg function as this could lead to injury. It was understood that this incident was not due to any failure or malfunction of the device, but rather improper use. Further instruction will be provided to the end-user as to proper use and operation of the seating once end-user receives medical clearance to continue use of the device. The dhr was reviewed and device met specification prior to distribution.
Patient Sequence No: 1, Text Type: N, H10
[184111617]
A report was received stating as the end-user was using their device in effort to reposition their depth in the seating, they received an injury to one of their legs requiring medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221084-2020-00006 |
| MDR Report Key | 9699707 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2019-12-27 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2019-04-25 |
| Date Added to Maude | 2020-02-12 |
| 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 AB |
| Manufacturer Street | PER UDDENS VAG 20 |
| Manufacturer City | TIMRA, 861 23 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 861 23 |
| 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 | 2020-02-12 |
| Model Number | F5 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERMOBIL AB (PAB) |
| Manufacturer Address | PER UDDENS VAG 13 TIMRA, 861023 SW 861023 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-02-12 |