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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DJO, LLC 20-30 SURG THCT BAND; STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES)
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DJO, LLC 20-30 SURG THCT BAND; STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES) Back to Search Results
Model Number ETI000205
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Injury (2348)
Event Date 10/17/2019
Event Type  Injury  
Manufacturer Narrative
Investigation is pending receipt and evaluation of the product.
 
Event Description
It was reported that the product caused the patient to "undergo leg surgery in both legs.Claims were made that she had gotten aggressively worse due to the wrong size." no information is currently available regarding the specific patient condition that required intervention.
 
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Brand Name
20-30 SURG THCT BAND
Type of Device
STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES)
Manufacturer (Section D)
DJO, LLC
1430 decision street
vista CA 92081
Manufacturer (Section G)
LEGS 4 LIFE, LLC
300 industrial park ave
asheboro NC 27205
Manufacturer Contact
brian becker
1430 decision street
vista, CA 92081
MDR Report Key9316722
MDR Text Key174181946
Report Number3004116007-2019-00001
Device Sequence Number1
Product Code FQL
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberETI000205
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/17/2019
Initial Date FDA Received11/13/2019
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 Number1
Patient Outcome(s) Required Intervention;
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