MAUDE Adverse Event Report: DJO LLC KATY GREEN/TURQUOISE 8 1/2 XWI; ORTHOSIS, CORRECTIVE SHOE

Model Number 37725-X-08.5

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

Patient Problem Ulcer (2274)

Event Date 09/29/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that allegedly the shoe was rubbing on left toe too tight and caused and ulcer on the patient's foot causing in home health care for the wound for 8 months.The shoe was returned to enovis for investigation.After evaluating the shoe, no defect could be confirmed.

Event Description

It was reported that allegedly the shoe was rubbing on left toe too tight and caused and ulcer on the patient's foot causing in home health care for the wound for 8 months.

• Brand Name: KATY GREEN/TURQUOISE 8 1/2 XWI
• Type of Device: ORTHOSIS, CORRECTIVE SHOE
• 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: 15670256
• MDR Text Key: 302400270
• Report Number: 9616086-2022-00028
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 37725-X-08.5
• Device Lot Number: KS-44-21
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/29/2022
• 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 Sex: Female