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TPLC
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show TPLC since
2009
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2019
2020
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2024
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Device
aid, transfer
Product Code
IKX
Regulation Number
890.5050
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
833
833
2015
39
39
2016
17
17
2017
16
16
2018
15
15
2019
14
14
2020
11
11
2021
5
5
2022
50
50
2023
12
12
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
308
308
Crack
198
198
Unstable
116
116
Bent
90
90
Device Slipped
55
55
Detachment Of Device Component
41
41
Product Quality Problem
35
35
Device Operates Differently Than Expected
30
30
Use of Device Problem
21
21
Torn Material
17
17
Collapse
16
16
Deformation Due to Compressive Stress
15
15
Adverse Event Without Identified Device or Use Problem
12
12
Unintended Movement
11
11
Detachment of Device or Device Component
11
11
Loose or Intermittent Connection
11
11
Mechanical Problem
11
11
Material Separation
10
10
Insufficient Information
9
9
Naturally Worn
8
8
Component Missing
7
7
Out-Of-Box Failure
6
6
Device Inoperable
6
6
Material Integrity Problem
5
5
Mechanical Jam
4
4
Split
4
4
Off-Label Use
4
4
Unraveled Material
4
4
Fracture
4
4
Inadequate or Insufficient Training
3
3
Patient-Device Incompatibility
3
3
Mechanics Altered
3
3
Human Factors Issue
2
2
Device Tipped Over
2
2
Connection Problem
2
2
Device Handling Problem
2
2
Material Split, Cut or Torn
2
2
Device Fell
2
2
Improper or Incorrect Procedure or Method
2
2
Device Damaged Prior to Use
2
2
Defective Component
2
2
Solder Joint Fracture
2
2
Device Issue
2
2
Failure to Align
2
2
Component Falling
2
2
Misassembled
2
2
Material Frayed
2
2
Hole In Material
2
2
Entrapment of Device
2
2
Fail-Safe Design Failure
1
1
Fluid/Blood Leak
1
1
Difficult to Fold, Unfold or Collapse
1
1
Loss of or Failure to Bond
1
1
Corroded
1
1
Material Fragmentation
1
1
Incomplete or Missing Packaging
1
1
Suction Problem
1
1
Fitting Problem
1
1
Physical Resistance/Sticking
1
1
Noise, Audible
1
1
Patient Device Interaction Problem
1
1
Physical Property Issue
1
1
Appropriate Term/Code Not Available
1
1
Fail-Safe Problem
1
1
Incorrect Device Or Component Shipped
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Moisture or Humidity Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
615
615
No Known Impact Or Consequence To Patient
165
165
Fall
87
87
No Clinical Signs, Symptoms or Conditions
53
53
Injury
20
20
No Information
18
18
No Patient Involvement
15
15
Laceration(s)
12
12
Bruise/Contusion
12
12
Pain
9
9
Abrasion
8
8
Bone Fracture(s)
8
8
Death
7
7
Discomfort
7
7
Physical Entrapment
6
6
Skin Tears
4
4
Insufficient Information
4
4
Patient Problem/Medical Problem
3
3
Strangulation
3
3
Hip Fracture
3
3
Fracture, Arm
3
3
Pyrosis/Heartburn
2
2
Blood Loss
2
2
No Code Available
2
2
Cramp(s) /Muscle Spasm(s)
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Tissue Breakdown
1
1
Hematoma
1
1
Hemorrhage/Bleeding
1
1
Inflammation
1
1
Coagulation Disorder
1
1
Joint Dislocation
1
1
Tooth Fracture
1
1
Neck Pain
1
1
Suture Abrasion
1
1
Ulceration
1
1
Concussion
1
1
Spinal Column Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
AliMed Corporation
II
Jan-22-2009
2
EOS Imaging
II
Jun-23-2017
3
Handicare USA, Inc.
II
Oct-24-2016
4
Handicare USA, Inc.
II
May-14-2015
5
Medline Industries Inc
II
Oct-05-2020
6
Medline Industries Inc
II
Nov-21-2017
7
North Coast Medical Inc
II
Apr-16-2012
8
Nutech Manufacturing Corp
II
Dec-01-2009
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