MAUDE Adverse Event Report: DJO, LLC AIRCAST SP-WALKER, MEDIUM; JOINT, ANKLE, EXTERNAL BRACE

Model Number 01A-M

Device Problem Crack (1135)

Patient Problem Bruise/Contusion (1754)

Event Date 06/26/2019

Event Type  malfunction  

Manufacturer Narrative

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 "just below the hinged part of the top of the boot (so not on any weight-bearing section), the plastic has cracked.While it's not a huge crack, it has resulted in an additional injury to me, because the hinged part was pressing against my shin, leaving a sore red spot about the size of a $2 coin, that is extremely sensitive to the touch.It also renders the boot basically unusable - if i needed to use it again, i could not, because of this break." no additional information has been provided at this time.

• Brand Name: AIRCAST SP-WALKER, MEDIUM
• 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: 8835893
• MDR Text Key: 208333727
• Report Number: 9616086-2019-00051
• Device Sequence Number: 1
• Product Code: ITW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 07/29/2019

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: 01A-M
• Device Lot Number: 190113-BB
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1