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TPLC
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show TPLC since
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2024
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Device
adaptor, hygiene
Product Code
ILS
Regulation Number
890.5050
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
705
705
2015
702
702
2016
411
411
2017
48
48
2018
36
36
2019
50
50
2020
32
32
2021
27
27
2022
45
45
2023
59
59
2024
14
14
Device Problems
MDRs with this Device Problem
Events in those MDRs
Crack
755
755
Break
446
446
Bent
215
215
Unstable
142
142
Collapse
81
81
Out-Of-Box Failure
68
68
Device Operates Differently Than Expected
58
58
Detachment Of Device Component
44
44
Material Integrity Problem
43
43
Product Quality Problem
40
40
Adverse Event Without Identified Device or Use Problem
39
39
Component Missing
33
33
Device Slipped
31
31
Fracture
31
31
Split
24
24
Material Twisted/Bent
24
24
Loose or Intermittent Connection
22
22
Mechanical Problem
20
20
Insufficient Information
19
19
Component Falling
18
18
Detachment of Device or Device Component
17
17
Deformation Due to Compressive Stress
17
17
Unintended Movement
17
17
Material Fragmentation
12
12
Corroded
11
11
Mechanics Altered
11
11
Device Dislodged or Dislocated
10
10
Material Separation
10
10
Material Deformation
10
10
Torn Material
10
10
Connection Problem
8
8
Mechanical Jam
8
8
Unraveled Material
8
8
Structural Problem
7
7
Sticking
7
7
Device Inoperable
7
7
Use of Device Problem
7
7
Appropriate Term/Code Not Available
7
7
Scratched Material
6
6
Improper or Incorrect Procedure or Method
6
6
Degraded
6
6
Device Damaged Prior to Use
5
5
Defective Component
5
5
Defective Device
4
4
Device Tipped Over
4
4
Leak/Splash
4
4
Misassembly by Users
4
4
Hole In Material
3
3
Naturally Worn
3
3
Positioning Problem
3
3
Material Protrusion/Extrusion
2
2
Device Contamination with Chemical or Other Material
2
2
Human-Device Interface Problem
2
2
Installation-Related Problem
2
2
Malposition of Device
2
2
Calibration Problem
2
2
Failure to Align
2
2
Fluid/Blood Leak
2
2
Bolus mechanism failure
2
2
Burst Container or Vessel
2
2
Material Too Rigid or Stiff
2
2
Fitting Problem
2
2
Temperature Problem
2
2
Noise, Audible
2
2
Patient Device Interaction Problem
2
2
Sharp Edges
2
2
No Apparent Adverse Event
1
1
Missing Value Reason
1
1
Inadequate Service
1
1
Shipping Damage or Problem
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Melted
1
1
Peeled/Delaminated
1
1
Material Puncture/Hole
1
1
Material Frayed
1
1
Disconnection
1
1
Material Disintegration
1
1
Entrapment of Device
1
1
Flaked
1
1
Dent in Material
1
1
Difficult or Delayed Activation
1
1
Computer Operating System Problem
1
1
Incomplete or Missing Packaging
1
1
Solder Joint Fracture
1
1
Tear, Rip or Hole in Device Packaging
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Failure of Device to Self-Test
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
994
994
No Consequences Or Impact To Patient
465
465
Fall
274
274
Injury
81
81
No Information
70
70
Bruise/Contusion
62
62
Bone Fracture(s)
46
46
Laceration(s)
40
40
Pain
35
35
Head Injury
35
35
Complaint, Ill-Defined
29
29
Discomfort
26
26
No Code Available
24
24
No Patient Involvement
18
18
Skin Tears
15
15
Physical Entrapment
10
10
Concussion
10
10
Insufficient Information
10
10
No Clinical Signs, Symptoms or Conditions
9
9
Hip Fracture
9
9
Abrasion
9
9
Swelling
9
9
Limb Fracture
7
7
Hemorrhage/Bleeding
6
6
Hematoma
5
5
Neck Pain
5
5
Fracture, Arm
4
4
Joint Dislocation
4
4
Sprain
4
4
Erythema
4
4
Swelling/ Edema
4
4
Vertebral Fracture
4
4
Muscle/Tendon Damage
3
3
Contusion
3
3
Tooth Fracture
3
3
Post Traumatic Wound Infection
2
2
Loss of consciousness
2
2
Unspecified Infection
2
2
Pressure Sores
2
2
Collapse
2
2
Death
2
2
Hemorrhage, Subdural
2
2
Muscular Rigidity
2
2
Damage to Ligament(s)
2
2
Loss of Range of Motion
2
2
Intervertebral Disc Compression or Protrusion
2
2
Easy Bruising
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Blister
1
1
Skin Infection
1
1
Skin Discoloration
1
1
Skin Irritation
1
1
Vertigo
1
1
Vomiting
1
1
Chills
1
1
Memory Loss/Impairment
1
1
Muscle Spasm(s)
1
1
Undesired Nerve Stimulation
1
1
Intracranial Hemorrhage
1
1
Hyperglycemia
1
1
Failure of Implant
1
1
Incontinence
1
1
Gangrene
1
1
Dyspnea
1
1
Edema
1
1
Emotional Changes
1
1
Burn(s)
1
1
Coma
1
1
Inadequate Pain Relief
1
1
Deformity/ Disfigurement
1
1
Ulcer
1
1
Cognitive Changes
1
1
Blood Loss
1
1
Needle Stick/Puncture
1
1
Suture Abrasion
1
1
Shaking/Tremors
1
1
Multiple Fractures
1
1
Unspecified Kidney or Urinary Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Etac Supply Center Ab
II
Aug-13-2015
2
Etac Supply Center Ab
II
Jul-15-2015
3
Gf Health Products
II
Apr-05-2021
4
James Leckey Design Ltd
II
Apr-08-2020
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