MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-07 for PERMOBIL M3 CORPUS N/A manufactured by Permobil Inc..
[184110799]
Permobil received report claiming the end-user reported having fallen out of their seating on 3 separate occasions; in conjunction with one of the seat functions not operating properly and the service provider being unable to identify the alleged problem. A permobil representative met with the end-user and dealer to inspect and evaluate the device, and to interview the end-user regarding the reports of falling. Inspection shown the device to be fully operational with no indications of a malfunction or deviation in operation having occurred. It was determined the alleged issues were the result of the end-users misunderstanding of the seat function operation. Inquiries were made as to where and how the reported falls occurred. The end-user reported having lost balance while attempting to perform a stand and pivot transfer from the device to a commode. During one of these falls, the end-user was reported to have sustained a cut on their toe. End-user claimed having sought a medical evaluation from their physician, but was not forthcoming as severity of the injury or the results of the reported evaluation. No allegations or claims were made that a device failure or malfunction contributed to reported falls. Further product training has been provided to the end-user to ensure proper operation and transfer techniques are being performed. The dhr was reviewed and unit was built according to specification prior to distribution.
Patient Sequence No: 1, Text Type: N, H10
[184110800]
Reports while end-user was in process of transferring, they reportedly lost their balance and fell. As a result of the fall it was reported they had cut their toe to which they sought a medical evaluation from their physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221084-2020-00005 |
| MDR Report Key | 9683708 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-01-02 |
| Date Mfgr Received | 2020-01-10 |
| Device Manufacturer Date | 2018-04-26 |
| Date Added to Maude | 2020-02-07 |
| 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 37090 |
| Manufacturer Country | US |
| Manufacturer Postal | 37090 |
| Manufacturer Phone | 8007360925 |
| Manufacturer G1 | PERMOBIL INC. |
| Manufacturer Street | 300 DUKE DR. |
| 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 M3 CORPUS |
| Generic Name | POWER WHEELCHAIR |
| Product Code | ITI |
| Date Received | 2020-02-07 |
| Model Number | M3 CORPUS |
| 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 37090 US 37090 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-07 |