MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M300; POWERED WHEELCHAIR

Model Number M300

Device Problem Device-Device Incompatibility (2919)

Patient Problem Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

Investigation is pending and the exact failure mode is inconclusive at this time.The distributing dealer installed an aftermarket seat cushion called "enhancer roho seat cushion".End user reported that the suspect seat cushion's rear thickness produced a gap between the seat and back that led to his injury.However, the dealer is unsure if the wheelchair contributed to the alleged injury or if the injury was sustained from a pump malfunction with patient's medical bed mattress; a problem that occurred around the same time.The exact date of this incident is unknown.An on-going investigation is active and a follow up mdr will be submitted once finalized results have been established.The dhr for this device was reviewed and the wheelchair met specification prior to distribution.Note: the manufacture of suspect seat cushion has been informed of customer's complaint.

Event Description

Patient states that the aftermarket seat cushion and the original backrest cushion do not meet in the rear of the seat and has a 2 - 3 inch gap.Patient claims this caused a blood blister on his bottom and resulted in surgery.

• Brand Name: PERMOBIL M300
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer (Section G): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: shawn waynick ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 5599509
• MDR Text Key: 43435212
• Report Number: 1221084-2016-00019
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2016
• Initial Date FDA Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 104