MAUDE Adverse Event Report: RESTORATIVE CARE OF AMERICA, INC. TA / WALKING BOOT; COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT

Model Number TA SERIES

Device Problem Mechanics Altered (2984)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2016

Event Type  malfunction  

Event Description

The two side screws - that the side supports vertically - fell out, the screws were reattached.The clinic reported this is not the first time this has happened with this boot, from this manufacturer, on other patients.Manufacturer response for walking boot, ta / walking boot (per site reporter): the clinic has informed the manufacturer more than once about this recurring problem.Unknown response.Clinic will no longer use this manufacturer as the problem is not being corrected.

• Brand Name: TA / WALKING BOOT
• Type of Device: COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT
• Manufacturer (Section D): RESTORATIVE CARE OF AMERICA, INC.; 12221 33rd street north; st. petersburg FL 33716
• MDR Report Key: 5593436
• MDR Text Key: 43178984
• Report Number: 5593436
• Device Sequence Number: 1
• Product Code: IQI
• 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: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TA SERIES
• Device Catalogue Number: 78TA SERIES
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 16 YR