MAUDE Adverse Event Report: DJO, LLC AIRCAST XP DIABETIC WALKER SYSTEM, M; SHOE, CAST

Model Number 01PD-M

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

Patient Problem Pressure Sores (2326)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

The device has been received by the manufacturer and is pending completion of evaluation.A follow-up report will be submitted upon conclusion of the manufacturer's investigation.

Event Description

It was reported that, after a short time of wearing, a severe ulcer formed on the lateral side of the diabetic patient's ankle.The orthopaedic technician explained on telephone that the ankle of the patient is slightly tilted to the outside.This anomaly caused the ankle to wear through the inner cushion and rubbing on the plastic frame.No further information is currently available.

Manufacturer Narrative

One xp diabetic walker system, m, lot number 170817-bb, was returned for evaluation.Product conditions were visually evaluated and tested.The product is in good condition.No defect was found.There was no evidence (fragmentation or marking) on the liner that would prove contact or friction between the skin and the liner.The air cells were tested and inflated / deflated correctly.A definitive root cause cannot be determined.However, the reporter stated that patient's ankle "is slightly tilted to the outside.This anomaly caused the ankle to wear through the inner cushion and rubbing on the plastic frame." instructions for use state "like all lower extremity immobilizers, such as casts or braces, patients without sensation (i.E.Postop anesthesia, neuropathies, etc.) should be monitored frequently for "hot spots", skin irritation or wound management." this product is intended for people with diabetes, which is commonly associated with neuropathy in the lower extremities.

• Brand Name: AIRCAST XP DIABETIC WALKER SYSTEM, M
• Type of Device: SHOE, CAST
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 96081 9663
• MDR Report Key: 9207291
• MDR Text Key: 163132944
• Report Number: 9616086-2019-00072
• Device Sequence Number: 1
• Product Code: IPG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 01PD-M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention