MAUDE Adverse Event Report: DJO, LLC. PROCARE CLINIC 3-PANEL KNEE 24 SPLINT; JOINT, KNEE, EXTERNAL BRACE

Model Number 79-80180

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/16/2021

Event Type  malfunction  

Event Description

Pressure injury found.Patient has knee immobilizer in her room that she was to wear for 2 weeks after surgical procedure on the left lower extremity (lle).The immobilizer was placed on the leg by this wound nurse and mechanism of injury was found to line up with the metal rods within the immobilizer.

• Brand Name: PROCARE CLINIC 3-PANEL KNEE 24 SPLINT
• Type of Device: JOINT, KNEE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC.; 1430 decision st; vista CA 92081
• MDR Report Key: 11824691
• MDR Text Key: 250684291
• Report Number: 11824691
• Device Sequence Number: 1
• Product Code: ITQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/04/2021,03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 79-80180
• Device Catalogue Number: 79-80180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2021
• Date Report to Manufacturer: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29565 DA
• Patient Weight: 62