MAUDE Adverse Event Report: DR COMFORT, A DJO, LLC COMPANY DR COMFORT; PERFORMANCE BLUE 12 WIDE

Model Number 7650-W-12.0

Device Problem Naturally Worn (2988)

Patient Problem Post Traumatic Wound Infection (2447)

Event Date 06/12/2017

Event Type  Injury  

Event Description

Complaint received that alleges "posterior proximal edge of the heel cup digs into his achilles tendon, it was digging into his tendon every time he took a step or plantar flexed his foot while wearing the shoe.If you look closely you can see that there is a little bit of a difference in the angle from one shoe to the other.He ended up being hospitalized for an infection and he was there for a while".Questionnaire not received from customer or clinician.Device was returned to manufacturer for evaluation.I reviewed the shoes and noticed that the heel counter is smashed down, indicating that the patient walks on the back of the heel.

• Brand Name: DR COMFORT
• Type of Device: PERFORMANCE BLUE 12 WIDE
• Manufacturer (Section D): DR COMFORT, A DJO, LLC COMPANY; 10300 enterprise drive; mequon 53092
• Manufacturer (Section G): DR COMFORT, A DJO, LLC COMPANY; 10300 enterprise drive; mequon 53092
• Manufacturer Contact: william fisher ; 1430 decision street; vista, CA 92081-9663
• MDR Report Key: 6660325
• MDR Text Key: 78179144
• Report Number: 3008579854-2017-00003
• Device Sequence Number: 1
• Product Code: KNP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 7650-W-12.0
• Device Lot Number: 6567022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• 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