PERMOBIL M3 CORPUS N/A

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number1221084-2020-00003
MDR Report Key9659929
Report SourceDISTRIBUTOR
Date Received2020-02-03
Date of Report2020-02-03
Date of Event2019-11-19
Date Mfgr Received2020-01-08
Device Manufacturer Date2019-11-07
Date Added to Maude2020-02-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. KEVIN BULLOCK
Manufacturer Street300 DUKE DR.
Manufacturer CityLEBANON TN 37090
Manufacturer CountryUS
Manufacturer Postal37090
Manufacturer Phone8007360925
Manufacturer G1PERMOBIL INC.
Manufacturer Street300 DUKE DR.
Manufacturer CityLEBANON TN 37090
Manufacturer CountryUS
Manufacturer Postal Code37090
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePERMOBIL M3 CORPUS
Generic NamePOWER WHEELCHAIR
Product CodeITI
Date Received2020-02-03
Model NumberM3 CORPUS
Catalog NumberN/A
Lot NumberN/A
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPERMOBIL INC.
Manufacturer Address300 DUKE DR. LEBANON TN 37090 US 37090


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-02-03

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