MAUDE Adverse Event Report: DJO, LLC AIRCAST; AIRSELECT, SHORT, MEDIUM

Model Number 01ES-M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 06/15/2017

Event Type  Injury  

Event Description

Complaint received that alleges "after three weeks of wearing the boot the right aircel became defective and the pressure of the aircel on the left pushed her ankle into the right side of the boot causing a blister to form.Customer has a history of neuropathy and the blister became infected after covering it.The blister and swelling needed to be lanced and packed to heal.Had to go to the er and have an mri on the ankle".Questionnaire not received from customer or clinician.Device not received manufacturer at this time.

• Brand Name: AIRCAST
• Type of Device: AIRSELECT, SHORT, MEDIUM
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, 22244 ; MX 22244
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081-9663
• MDR Report Key: 6801052
• MDR Text Key: 82931476
• Report Number: 9616086-2017-00016
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 01ES-M
• Device Lot Number: 161123-BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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