MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-19 for PERMOBIL C500 N/A manufactured by Permobil Ab (pab).
[184113938]
Report indicated as the end-user was in process of dressing themselves, they were resting their weight on the armrest of the seating for support. During this process, it was reported the armrest suddenly gave way and fell down from the horizontal position. This loss of armrest positioning reportedly caused the end-user to lose their balance and fall to the floor. Reports indicate the end-user was taken to the hospital where they were diagnosed as having suffered fractured teeth and various lacerations to their nose and chin, some requiring stitches to remedy. Inspection of the device shown the threaded rod portion of the link arm (which maintains the armrest angle) on the right side armrest having broken where it attaches to the armrest. This failure allowed the armrest to lose support and fall down. The corpus 3g user manual, which was provided with the device, indicates safety warnings outlining the armrest as not being intended to sustain heavy loads. At this point permobil is unable to determine the root cause of the component failure. Investigation will continue and upon receipt of any new information a follow-up report will be submitted. The dhr was reviewed and the device met specification prior to distribution.
Patient Sequence No: 1, Text Type: N, H10
[184113939]
Received report claiming as the end-user was leaning on the armrest while attempting to dress, the right armrest was reported to have fallen down causing the end-user to lose balance and fall to the floor. The fall was reported to have resulted in an injury requiring medical intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221084-2020-00015 |
| MDR Report Key | 9854642 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2016-10-07 |
| Date Added to Maude | 2020-03-19 |
| 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 36 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 861 36 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERMOBIL C500 |
| Generic Name | POWERED WHEELCHAIR |
| Product Code | ITI |
| Date Received | 2020-03-19 |
| Model Number | C500 |
| 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, 861 36 SW 861 36 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-19 |