MAUDE Adverse Event Report: DJO LLC. PROCARE POST OP SHOE; SHOE, CAST

Model Number 79-81135

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

Health professional, occupation: unknown.Mfr site: unknown.Device not received manufacturer at this time.Manufacturer is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

It was reported that "there was a quality issue with the device (regarding the velcro straps) that resulted in foot wounds (skin damage) to the patient." the device has not been returned for evaluation.There is no further information available at this time.

• Brand Name: PROCARE POST OP SHOE
• Type of Device: SHOE, CAST
• Manufacturer (Section D): DJO LLC.; 1430 decision street; vista CA 92081
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S. A. DE C. V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, b.c., mx 22244 ; MX 22244
• Manufacturer Contact: christine bonczyk ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 10791191
• MDR Text Key: 214750718
• Report Number: 9616086-2020-00035
• Device Sequence Number: 1
• Product Code: IPG
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 79-81135
• Date Manufacturer Received: 09/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1