MAUDE Adverse Event Report: DJO GLOBAL COMPANY PROCARE POST OP SHOE; MED/SURG SHOE - SIZE L ORTHOSIS, CORRECTIVE SHOE

Model Number 79-81147

Device Problem Break (1069)

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

Event Date 06/01/2017

Event Type  malfunction  

Event Description

Patient presented to medical office with broken post op shoe.The velcro just fell apart on her.Rn got patient another shoe and the same issue happened with the brand new one.

• Brand Name: PROCARE POST OP SHOE
• Type of Device: MED/SURG SHOE - SIZE L ORTHOSIS, CORRECTIVE SHOE
• Manufacturer (Section D): DJO GLOBAL COMPANY; vista CA 92081
• MDR Report Key: 6646882
• MDR Text Key: 77864583
• Report Number: MW5070447
• Device Sequence Number: 1
• Product Code: IPG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/14/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 79-81147
• Device Catalogue Number: E-416197
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1