MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-19 for PERMOBIL M300 N/A manufactured by Permobil Inc..
[184132086]
Permobil's general counsel received a complaint filed by the end-user's family alleging that his m300 caught fire at his residence due supposedly to negligent design and unspecified component malfunctions. The complaint alleges the end-user sustained fourth-degree burns over his entire body because he was unable to remove himself from the device due to his disability and/or physical handicap. The end user subsequently passed away. Permobil has been unable to confirm the allegation of a device failure/malfunction because the device has not been made available for permobil to inspect. Permobil previously learned of this person's death, but there was no allegation at the time that a permobil device was involved and permobil was unable to determine whether a permobil device was involved. Permobil was also told that this person's manner of death was suicide and that this person had intentionally started the fire at issue. Permobil will continue to work through counsel in efforts to gather more information. Upon receipt of new information, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[184132087]
Permobil received a notice of petition alleging while the end-user was at his residence, the m300 had caught fire with the end-user in the seating. Claim indicates the end-user sustained grave injuries and subsequently deceased.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221084-2020-00014 |
| MDR Report Key | 9854582 |
| Report Source | OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2018-02-26 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2015-04-29 |
| 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 | 0 |
| 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 | 2020-03-19 |
| Model Number | M300 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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. Death | 2020-03-19 |