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TPLC
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show TPLC since
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2024
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Device
restraint, protective
Product Code
FMQ
Regulation Number
880.6760
Device Class
1
Premarket Reviews
Manufacturer
Decision
CHILDREN'S HEALTH FIRST, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDI-TECH INTL. CORP.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
43
43
2015
33
33
2016
24
24
2017
54
54
2018
23
23
2019
57
57
2020
38
38
2021
33
33
2022
54
54
2023
47
47
2024
21
21
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
117
117
Adverse Event Without Identified Device or Use Problem
46
46
Device Slipped
34
34
Mechanical Problem
30
30
Insufficient Information
18
18
Material Split, Cut or Torn
15
15
Device Operates Differently Than Expected
14
14
Torn Material
13
13
Material Integrity Problem
12
12
Improper or Incorrect Procedure or Method
12
12
Device Contaminated During Manufacture or Shipping
11
11
Material Separation
9
9
Defective Device
9
9
Defective Component
8
8
Patient Device Interaction Problem
7
7
Detachment Of Device Component
7
7
Detachment of Device or Device Component
6
6
Mechanics Altered
6
6
Product Quality Problem
6
6
Material Frayed
5
5
Positioning Problem
5
5
Labelling, Instructions for Use or Training Problem
5
5
Material Rupture
4
4
Misassembled
4
4
Material Disintegration
4
4
Human-Device Interface Problem
4
4
Fail-Safe Problem
3
3
Connection Problem
3
3
Difficult to Open or Close
3
3
Stretched
3
3
Microbial Contamination of Device
2
2
Inadequacy of Device Shape and/or Size
2
2
Protective Measures Problem
2
2
No Apparent Adverse Event
2
2
Therapeutic or Diagnostic Output Failure
2
2
Use of Device Problem
2
2
Degraded
2
2
Difficult or Delayed Separation
2
2
Appropriate Term/Code Not Available
2
2
Activation, Positioning or Separation Problem
2
2
Unraveled Material
2
2
Inadequate Instructions for Healthcare Professional
1
1
Device Difficult to Setup or Prepare
1
1
Structural Problem
1
1
Escape
1
1
Difficult to Remove
1
1
Tear, Rip or Hole in Device Packaging
1
1
Off-Label Use
1
1
Device Emits Odor
1
1
Device Handling Problem
1
1
Sticking
1
1
Unintended Movement
1
1
Nonstandard Device
1
1
Crack
1
1
Material Too Soft/Flexible
1
1
Disconnection
1
1
Moisture Damage
1
1
Loose or Intermittent Connection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
116
116
No Consequences Or Impact To Patient
95
95
No Known Impact Or Consequence To Patient
59
59
Extubate
34
34
Insufficient Information
19
19
No Patient Involvement
15
15
Fall
12
12
No Code Available
10
10
No Information
9
9
Not Applicable
6
6
Skin Tears
6
6
Death
6
6
Emotional Changes
5
5
Irritability
5
5
Bruise/Contusion
4
4
Skin Erosion
4
4
Bone Fracture(s)
3
3
Loss of consciousness
3
3
Injury
3
3
Confusion/ Disorientation
3
3
Choking
2
2
Skin Irritation
2
2
Laceration(s)
2
2
Anxiety
2
2
Unintended Extubation
2
2
Unspecified Tissue Injury
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Complaint, Ill-Defined
1
1
Therapeutic Response, Decreased
1
1
Pain
1
1
Paresis
1
1
Concussion
1
1
Head Injury
1
1
Hematoma
1
1
Hemorrhage/Bleeding
1
1
Irritation
1
1
Cardiopulmonary Arrest
1
1
Blood Loss
1
1
Device Embedded In Tissue or Plaque
1
1
Fracture, Arm
1
1
Ventilator Dependent
1
1
Reinfusion
1
1
Numbness
1
1
Abrasion
1
1
Sweating
1
1
Needle Stick/Puncture
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DeRoyal Industries Inc
II
Aug-22-2022
2
DeRoyal Industries Inc
II
Mar-30-2020
3
DeRoyal Industries Inc
II
Mar-14-2014
4
J T Posey Company
II
Apr-09-2013
5
J T Posey Company
II
Sep-22-2009
6
J T Posey Company
II
Feb-03-2009
7
Med Tec Inc
II
Sep-14-2015
8
Med Tec Inc
II
Jan-15-2015
9
Queen Comfort Products lLC
II
Nov-01-2021
10
TIDI PRODUCTS
II
Oct-25-2019
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