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

Model Number 01EP-M

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

Patient Problem Pressure Sores (2326)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

Not returned.

Event Description

Complaint received that alleges "after a few weeks, he developed a blister (about the size of an orange) on the sole of his foot, from the heel to almost the middle of his sole.The blister was drained and treated by the doctor.The blister turned into a full-blown pressure wound which we have been treating since (b)(6).It is now (b)(6) and we are still treating this wound.Every week we go to a wound center for treatment, to his doctor's office and we also treat the wound at home (i am the "nurse" at home) with medical supplies that are purchased through a vendor of the wound center".Questionnaire not received from customer or clinician.Device not returned to manufacturer for evaluation.

Manufacturer Narrative

Not returned.

• Brand Name: AIRCAST
• Type of Device: AIRSELECT, ELITE, 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, mexico 22244 ; MX 22244
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081 ; 7607313126
• MDR Report Key: 6342564
• MDR Text Key: 67801104
• Report Number: 9616086-2017-00004
• Device Sequence Number: 1
• Product Code: IQI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date: 02/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 01EP-M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2017
• 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): Other