MAUDE Adverse Event Report: DJO, LLC DR. COMFORT ANNIE BEIGE 11 WIDE; ORTHOSIS, CORRECTIVE SHOE

Model Number 4530-W-11.0

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

The shoe was returned for evaluation.There was a nail planted inside and poking through the tongue of the shoe.The complaint investigation takes into consideration the potential risks associated with this incident.The cause has not been established at this time.

Event Description

It was reported that there is a nail in the base of the tongue of the left shoe that poked the patient's foot when trying it on.No further information is currently available.

• Brand Name: DR. COMFORT ANNIE BEIGE 11 WIDE
• Type of Device: ORTHOSIS, CORRECTIVE SHOE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DR. COMFORT, A DJO, LLC COMPANY; 10300 enterprise dr.; mequon WI 59092
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 9225566
• MDR Text Key: 184332541
• Report Number: 3008579854-2019-00013
• Device Sequence Number: 1
• Product Code: KNP
• 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
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4530-W-11.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1