MAUDE Adverse Event Report: DJO, LLC AIRCAST XP DIABETIC WALKER SYSTEM, S; JOINT, ANKLE, EXTERNAL BRACE

Model Number 01PD-S

Device Problem Material Separation (1562)

Patient Problem Laceration(s) (1946)

Event Date 06/14/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: unknown.No device was returned for evaluation.If the device is received, a follow-up report will be submitted upon completion of product evaluation.

Event Description

It was reported that the air cell attached to the anterior panel had moved and was not in the correct place, causing the plastic part to rub and "cheese grate" the patient's foot.No further information was provided.

• Brand Name: AIRCAST XP DIABETIC WALKER SYSTEM, S
• Type of Device: JOINT, ANKLE, EXTERNAL BRACE
• Manufacturer (Section D): DJO, LLC; 1430 decision street; vista CA 92081 9663
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 submetropoli el florido; tijuana, b.c. 22244, ; MX
• Manufacturer Contact: brian becker ; 2900 lake vista drive; lewisville, TX 75067
• MDR Report Key: 8775279
• MDR Text Key: 150531742
• Report Number: 9616086-2019-00048
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 01PD-S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention