MAUDE Adverse Event Report: DJO, LLC DR COMFORT L5000 TOE FILLER CUSTOM INSOLE; ORTHOSIS, CORRECTIVE SHOE

Model Number 17-0004-0-00000

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

Patient Problem Pressure Sores (2326)

Event Date 02/07/2020

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 "insert caused an ulcer at 1st metatarsal area.An open wound being treated by doctor".No further information is currently available.

Manufacturer Narrative

H3, h6: one l5000 toe filler custom insole, serial number (b)(6), was returned for evaluation.Upon inspection, no defect was confirmed.

• Brand Name: DR COMFORT L5000 TOE FILLER CUSTOM INSOLE
• Type of Device: ORTHOSIS, CORRECTIVE SHOE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista, ca
• MDR Report Key: 9717307
• MDR Text Key: 184332170
• Report Number: 3008579854-2020-00004
• Device Sequence Number: 1
• Product Code: KNP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 17-0004-0-00000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Date Manufacturer Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention