MAUDE Adverse Event Report: MD ORTHOPEDICS PONSETI MITCHELL BRACES; ORTHOSIS, CORRECTIVE SHOE

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

Patient Problems Erythema (1840); Pressure Sores (2326); Post Operative Wound Infection (2446)

Event Date 08/04/2017

Event Type  malfunction  

Event Description

Newborn wearing ponseti mitchell boots (braces); staff notes wounds on right foot and today noted stage iii pressure ulcer on her left posterior ankle from the boots.Also noted was erythema also on her right toe, stage i from pressure.Wound care nurse assessed ulcers; per nurse, physician states boots need to be tight.Nurses questions if vendor should be notified as boots should not cause multiple pressure ulcers.

• Brand Name: PONSETI MITCHELL BRACES
• Type of Device: ORTHOSIS, CORRECTIVE SHOE
• Manufacturer (Section D): MD ORTHOPEDICS; 604 north parkway st; wayland IA 52654
• MDR Report Key: 6842121
• MDR Text Key: 84869223
• Report Number: 6842121
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Outcome(s): Other
• Patient Weight: 2