MAUDE Adverse Event Report: DJO LLC L5000 TOE FILLER CUSTOM INSOLE; INSOLES, MEDICAL

Model Number 17-0004-0-00000

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem Ulcer (2274)

Event Date 01/10/2023

Event Type  Injury  

Event Description

It was reported that allegedly insert does not provide full contact with patients toe that caused a ulcer, the patient did seek medical attention.

Manufacturer Narrative

It was reported that allegedly insert does not provide full contact with patients toe that caused a ulcer.Medical intervention was required, it was reported by the doctor the medical treatment that was provided was debridement of ulcerations, offloading, and applications of skin graft substitute.The toe filler and shoes were returned to enovis for evaluation.The investigation found that there was no defect found with the shoes and the investigartion with toe fillers found that the toe filler was mis assembled 3/8 of space from filler to amp site was not included.

• Brand Name: L5000 TOE FILLER CUSTOM INSOLE
• Type of Device: INSOLES, MEDICAL
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; ste 200; carlsbad CA 92010
• Manufacturer (Section G): DJO, LLC; 10300 n enterprise dr; mequon WI 53092
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; ste 200; carlsbad, CA 92010
• MDR Report Key: 16301459
• MDR Text Key: 308822791
• Report Number: 9616086-2023-00003
• Device Sequence Number: 1
• Product Code: KYS
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 17-0004-0-00000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• 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
• Treatment: 3470-M-07.0 LOT: UNKNOWN
• Patient Outcome(s): Other