MAUDE Adverse Event Report: DJO, LLC DR COMFORT DOUGLAS BLACK 10 MED; ORTHOSIS, CORRECTIVE SHOE

Model Number 6610-M-10.0

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

Patient Problem Skin Inflammation (2443)

Event Date 01/02/2020

Event Type  Injury  

Manufacturer Narrative

No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.

Event Description

It was reported that the patient "got blisters on his heels for both feet (out heel for the left and back heel on the right).He was hospitalized but consulted a doctor.As per doctor, the incident might be caused by the shoes.The right foot has a sore still.They used iodine to heal the foot and covered it.".

• Brand Name: DR COMFORT DOUGLAS BLACK 10 MED
• Type of Device: ORTHOSIS, CORRECTIVE SHOE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081
• Manufacturer (Section G): DR. COMFORT, A DJO, LLC COMPANY; 10300 enterprise dr.; mequon WI 59092
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 9580985
• MDR Text Key: 174697567
• Report Number: 3008579854-2020-00001
• Device Sequence Number: 1
• Product Code: KNP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6610-M-10.0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2020
• 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