MAUDE Adverse Event Report: AIRCAST INC. AIRCAST PNEUMATIC WALKER

Model Number 01PXL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Laceration(s) (1946)

Event Date 07/23/2013

Event Type  Injury  

Event Description

After having cast removed from his right leg, my father was given an aircast orthopedic boot to begin his rehab for a broken leg.It was an aircast pneumatic walker model 01pxl.After 2 days in this booth, he had lacerations on the left, right, and rear of his leg from 3 to 6 inches long.Doctors discontinued this boot and had to wait for his leg to heal before continuing his rehab.After contacting the company, i was asked to forward the boot to someone in quality dept named (b)(6) for testing.As of this date, i have not heard from anyone as to the results after several calls to the company.Boot was shipped on (b)(4) 2013.

• Brand Name: AIRCAST PNEUMATIC WALKER
• Type of Device: AIRCAST PNEUMATIC WALKER
• Manufacturer (Section D): AIRCAST INC.
• MDR Report Key: 3561932
• MDR Text Key: 4073622
• Report Number: MW5033755
• Device Sequence Number: 1
• Product Code: IQI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 01PXL
• Patient Sequence Number: 1
• Treatment: WARFARIN; GLIMEPITIDE; SIMVASTAT; VITAMIN D; LANTIS; ASTEPRO; TORSEMIDE; CARVELDILOL; VITAMIN C; VITAMIN CQ 10; CERTIRIZINE; IPRATROPIUM.5/ALBUTEROL3 (IN NEBULIZER); SERTRALINE; ADVIR
• Patient Outcome(s): Hospitalization
• Patient Age: 87 YR
• Patient Weight: 95