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U.S. Department of Health and Human Services

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

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DJO, LLC AIRCAST SP-WALKER, MEDIUM; JOINT, ANKLE, EXTERNAL BRACE Back to Search Results
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.
 
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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 Key8835893
MDR Text Key208333727
Report Number9616086-2019-00051
Device Sequence Number1
Product Code ITW
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 Number01A-M
Device Lot Number190113-BB
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/04/2019
Initial Date FDA Received07/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/13/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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