MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-05 for PERMOBIL F5 N/A manufactured by Permobil Inc..
[177870043]
Reports provided by the end-users family member claim as the end-user was utilizing the device while in their garage, they were attempting to light a wood burning stove using a propane torch normally used for weed control. Reports indicate the end-user had lost their grip of the torch handle, dropping it in their lap which subsequently ignited the end-users clothing. Reports indicate the end-user was transported to the area burn center where they eventually succumbed and died after suffering 3rd degree burns to over 85% of their body. All accounts received claim this unfortunate incident was strictly use error and the device did not deviate or malfunction in any way to have contributed to this event. As the result of the external thermal activity, the device sustained considerable damages rendering it inoperable. The dhr was reviewed and device met specification prior to distribution.
Patient Sequence No: 1, Text Type: N, H10
[177870044]
Received report claiming as the end-user was attempting to light a wood burning stove with a torch, they inadvertently dropped the torch in their lap subsequently igniting their clothing. End-user was reported to have sustained grave injuries as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221084-2020-00004 |
| MDR Report Key | 9673483 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-14 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2016-08-15 |
| Date Added to Maude | 2020-02-05 |
| 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 DRIVE |
| Manufacturer City | LEBANON TN 37090 |
| Manufacturer Country | US |
| Manufacturer Postal | 37090 |
| Manufacturer Phone | 8007360925 |
| Manufacturer G1 | PERMOBIL INC. |
| Manufacturer Street | 300 DUKE DRIVE |
| Manufacturer City | LEBANON TN 37090 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37090 |
| 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 | 2020-02-05 |
| Model Number | F5 |
| 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 DRIVE LEBANON TN 37090 US 37090 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-05 |