MAUDE Adverse Event Report: DJO LLC AIRCAST AIRSELECT; ORTHOSIS, CORRECTIVE SHOE

Model Number 01EP-M

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that the airselect elite allegedly did not provide cushioning to support the calf.The patient reported severe pain in his calf.Djo has not yet received the device for investigation.Once the investigation is complete, djo will provide a supplemental report.

Event Description

It was reported that the airselect elite allegedly did not provide cushioning to support the calf.The patient reported severe pain in his calf.

• Brand Name: AIRCAST AIRSELECT
• Type of Device: ORTHOSIS, CORRECTIVE SHOE
• Manufacturer (Section D): DJO LLC; 1430 decision street; vista CA 92081
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S. A. DE C. V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, b.c. 22244 ; MX 22244
• Manufacturer Contact: jim pomeroy ; 1430 decision stree; vista, CA 92081 ; 5128346301
• MDR Report Key: 11381829
• MDR Text Key: 233724305
• Report Number: 9616086-2021-00002
• Device Sequence Number: 1
• Product Code: KNP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A#S-P#N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 01EP-M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 22 YR