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

Model Number 01EP-L

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

Patient Problem Post Operative Wound Infection (2446)

Event Date 11/19/2015

Event Type  Injury  

Manufacturer Narrative

Not returned.

Event Description

Complaint received that alleges "received the boot six weeks after his surgery.Once he was released to start weight bear on his leg he went to (b)(6) on (b)(6) 2015, while walking he started to feel rubbing over the area where his incision was healing.He stopped wearing the boot immediately and went in the water.On (b)(6) 2015 he went to the er complaining of redness and infection on his incision site.He says that he had to have multiple surgeries because of the infection over his surgical site.He claims that the doctors told him that the boot caused the infection".Questionnaire was not received from clinician and/or patient.Device not returned to manufacturer for evaluation.

• Brand Name: AIRCAST
• Type of Device: AIRSELECT, ELITE, LARGE
• 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: 5347621
• MDR Text Key: 35161409
• Report Number: 9616086-2016-00001
• Device Sequence Number: 1
• Product Code: IPG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 01EP-L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2015
• 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): Required Intervention