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TPLC
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Device
walker, mechanical
Product Code
ITJ
Regulation Number
890.3825
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
2782
2782
2015
1122
1122
2016
499
499
2017
131
131
2018
126
126
2019
114
114
2020
117
117
2021
81
81
2022
114
114
2023
140
140
2024
17
17
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
1609
1609
Unstable
833
833
Device Slipped
429
429
Crack
281
281
Product Quality Problem
273
273
Detachment Of Device Component
244
244
Bent
241
241
Device Operates Differently Than Expected
239
239
Adverse Event Without Identified Device or Use Problem
139
139
Mechanical Problem
116
116
Unintended Movement
93
93
Naturally Worn
91
91
Device Inoperable
90
90
Out-Of-Box Failure
86
86
Collapse
83
83
Fracture
74
74
Insufficient Information
74
74
Component Falling
73
73
Device Dislodged or Dislocated
59
59
Detachment of Device or Device Component
57
57
Component Missing
46
46
Loose or Intermittent Connection
45
45
Material Integrity Problem
45
45
Use of Device Problem
44
44
Appropriate Term/Code Not Available
33
33
Material Separation
29
29
Mechanical Jam
28
28
Sticking
27
27
Solder Joint Fracture
26
26
Material Protrusion/Extrusion
25
25
Material Twisted/Bent
24
24
Material Fragmentation
24
24
Device Tipped Over
21
21
Improper or Incorrect Procedure or Method
21
21
Deformation Due to Compressive Stress
20
20
Defective Component
18
18
Split
16
16
Defective Device
13
13
Material Deformation
12
12
Mechanics Altered
12
12
Torn Material
12
12
Sharp Edges
12
12
Device Damaged Prior to Use
10
10
Failure to Align
7
7
Difficult to Fold, Unfold or Collapse
7
7
Noise, Audible
7
7
Device Unsafe to Use in Environment
6
6
Material Disintegration
6
6
Material Frayed
5
5
Unintended Collision
5
5
Patient Device Interaction Problem
5
5
Device Fell
5
5
Device Handling Problem
4
4
Protective Measures Problem
4
4
Unintended System Motion
4
4
Off-Label Use
4
4
Device Maintenance Issue
4
4
Bolus mechanism failure
4
4
Device Issue
4
4
Device Misassembled During Manufacturing /Shipping
4
4
Connection Problem
3
3
Folded
3
3
Structural Problem
3
3
Hole In Material
3
3
Misassembled
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Positioning Problem
3
3
Misassembly by Users
3
3
Human-Device Interface Problem
3
3
No Apparent Adverse Event
2
2
Physical Property Issue
2
2
Misassembled During Installation
2
2
Peeled/Delaminated
2
2
Difficult To Position
2
2
Degraded
2
2
Entrapment of Device
2
2
Failure to Advance
2
2
Dent in Material
2
2
Device Displays Incorrect Message
2
2
Fitting Problem
2
2
Inadequacy of Device Shape and/or Size
2
2
Material Too Rigid or Stiff
2
2
Self-Activation or Keying
1
1
Inadequate Service
1
1
Device Stops Intermittently
1
1
Vibration
1
1
Incomplete or Missing Packaging
1
1
Malposition of Device
1
1
Patient-Device Incompatibility
1
1
Date/Time-Related Software Problem
1
1
Fail-Safe Design Failure
1
1
Fire
1
1
Disassembly
1
1
Partial Blockage
1
1
Accessory Incompatible
1
1
Device Alarm System
1
1
Migration or Expulsion of Device
1
1
Labelling, Instructions for Use or Training Problem
1
1
Function indicator light(s), failure of
1
1
Separation Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
2631
2631
No Known Impact Or Consequence To Patient
1283
1283
Fall
659
659
Bone Fracture(s)
199
199
Laceration(s)
152
152
Bruise/Contusion
120
120
Injury
107
107
No Information
94
94
Head Injury
80
80
Pain
48
48
Hip Fracture
41
41
No Clinical Signs, Symptoms or Conditions
33
33
Insufficient Information
23
23
Fracture, Arm
23
23
Abrasion
22
22
Discomfort
20
20
No Patient Involvement
20
20
Concussion
19
19
Skin Tears
16
16
Limb Fracture
13
13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
11
11
Easy Bruising
10
10
Contusion
10
10
Hematoma
9
9
Joint Dislocation
9
9
No Code Available
9
9
Tooth Fracture
8
8
Neck Pain
7
7
Spinal Column Injury
7
7
Damage to Ligament(s)
7
7
Death
7
7
Vertebral Fracture
7
7
Brain Injury
6
6
Complaint, Ill-Defined
5
5
Hemorrhage/Bleeding
5
5
Unspecified Infection
5
5
Muscle/Tendon Damage
5
5
Swelling/ Edema
5
5
Patient Problem/Medical Problem
5
5
Ambulation Difficulties
4
4
Headache
4
4
Loss of consciousness
4
4
Skull Fracture
4
4
Swelling
4
4
Tissue Damage
3
3
Rupture
3
3
Radiation Underdose
3
3
Wound Dehiscence
3
3
Post Traumatic Wound Infection
3
3
Lymphoma
3
3
Unspecified Tissue Injury
3
3
Foreign Body In Patient
2
2
Multiple Fractures
2
2
Suture Abrasion
2
2
Eye Injury
2
2
Intracranial Hemorrhage
2
2
Hemorrhage, Subdural
2
2
Pyrosis/Heartburn
2
2
Urinary Retention
2
2
Loss of Vision
2
2
Sprain
2
2
Disability
2
2
Physical Entrapment
2
2
Non-union Bone Fracture
1
1
Ventilator Dependent
1
1
Sensitivity of Teeth
1
1
Sweating
1
1
Strangulation
1
1
Soreness
1
1
Ulceration
1
1
Thrombus
1
1
Weakness
1
1
Vertigo
1
1
Inflammation
1
1
Hemorrhage, Cerebral
1
1
Memory Loss/Impairment
1
1
Muscle Spasm(s)
1
1
Pneumonia
1
1
Loss of Range of Motion
1
1
Scar Tissue
1
1
Sepsis
1
1
Shock
1
1
Hearing Loss
1
1
Bleeding
1
1
Cardiac Arrest
1
1
Chest Pain
1
1
Dehydration
1
1
Dyspnea
1
1
Ecchymosis
1
1
Edema
1
1
Emotional Changes
1
1
Erythema
1
1
Sleep Dysfunction
1
1
Cognitive Changes
1
1
Hematuria
1
1
Disc Impingement
1
1
Fluid Discharge
1
1
Balance Problems
1
1
Skin Infection
1
1
Drug Resistant Bacterial Infection
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Breg Inc
II
Nov-03-2023
2
Briggs Medical Service Company d.b.a. Mabis
II
Oct-28-2014
3
Central Purchasing LLC DBA Harbor Freight Tools
II
Apr-10-2014
4
Compass Health Brands (Corporate Office)
II
Jan-19-2022
5
Essential Medical Supply, Inc.
II
Aug-25-2010
6
Essential Medical Supply, Inc.
II
Jul-20-2009
7
Etac Supply Center Ab
II
Jul-14-2012
8
Invacare Corporation
II
Aug-23-2023
9
Invacare Corporation
II
Jun-05-2012
10
Invacare Corporation
II
Sep-27-2011
11
James Leckey Design Ltd
II
May-27-2021
12
Nova Ortho-Med Inc
II
Dec-21-2020
13
Nova Ortho-Med Inc
II
Oct-24-2016
14
Owens & Minor Distribution, Inc.
II
Nov-20-2014
15
R82 A/S
II
May-04-2020
16
Roscoe Medical Inc
II
Nov-12-2014
17
SVS LLC
II
Nov-20-2018
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