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U.S. Department of Health and Human Services

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

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DJO, LLC DR. COMFORT ANNIE BEIGE 11 WIDE; ORTHOSIS, CORRECTIVE SHOE Back to Search Results
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.
 
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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 Key9225566
MDR Text Key184332541
Report Number3008579854-2019-00013
Device Sequence Number1
Product Code KNP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 Number4530-W-11.0
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/03/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/27/2019
Initial Date FDA Received10/23/2019
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 Number1
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