MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-03 for PERMOBIL M3 CORPUS N/A manufactured by Permobil Inc..
[184110361]
Reports provided claim the end-user lost balance while attempting to perform a stand and pivot transfer. During the fall, the end-user was reported to have sustained a cut on their leg from what they believe was the footplate. Reports provided claim complications having occurred where the end-user generated blood clots around the wound area requiring hospitalization and surgery two separate occasions. Reports provided by the end-users physical therapist indicate the end-user was instructed not to transfer without assistance, but accounts of the incident indicate the end-user had attempted to perform transfer un-assisted. No reports or allegations were made that the device malfunctioned or deviated in any way to have contributed to this event. The end-user could not clearly communicate how the accident happened or what potentially caused the injury to their leg. The end-users daughter suggested it was the footplate, but the service provider inspected the device and could not identify any sharp edges or points which may have inflicted the reported wound. Further product training to being taken with the end-user and family members 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
[184110362]
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 leg, presumably from the footplate. Reports indicate the end-user having been hospitalized on 2 separate occasions due to wound not healing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221084-2020-00003 |
| MDR Report Key | 9659929 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-03 |
| Date of Report | 2020-02-03 |
| Date of Event | 2019-11-19 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2019-11-07 |
| Date Added to Maude | 2020-02-03 |
| 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 | 2020-02-03 |
| 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. Hospitalization | 2020-02-03 |