Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
Back to Search Results
Device
restraint, protective
Product Code
FMQ
Regulation Number
880.6760
Device Class
1
MDR Year
MDR Reports
MDR Events
2017
54
54
2018
23
23
2019
57
57
2020
38
38
2021
33
33
2022
12
12
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
68
68
Adverse Event Without Identified Device or Use Problem
42
42
Mechanical Problem
19
19
Insufficient Information
10
10
Improper or Incorrect Procedure or Method
10
10
Material Split, Cut or Torn
8
8
Device Slipped
8
8
Material Integrity Problem
6
6
Device Operates Differently Than Expected
5
5
Positioning Problem
5
5
Misassembled
4
4
Labelling, Instructions for Use or Training Problem
4
4
Defective Device
4
4
Material Separation
4
4
Detachment of Device or Device Component
3
3
Torn Material
3
3
Mechanics Altered
3
3
Unraveled Material
2
2
No Apparent Adverse Event
2
2
Therapeutic or Diagnostic Output Failure
2
2
Stretched
2
2
Patient Device Interaction Problem
2
2
Defective Component
2
2
Product Quality Problem
2
2
Inadequacy of Device Shape and/or Size
2
2
Tear, Rip or Hole in Device Packaging
1
1
Detachment Of Device Component
1
1
Difficult to Remove
1
1
Human-Device Interface Problem
1
1
Protective Measures Problem
1
1
Device Handling Problem
1
1
Use of Device Problem
1
1
Structural Problem
1
1
Inadequate Instructions for Healthcare Professional
1
1
Degraded
1
1
Appropriate Term/Code Not Available
1
1
Difficult to Open or Close
1
1
Moisture Damage
1
1
Material Frayed
1
1
Loose or Intermittent Connection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
61
61
No Known Impact Or Consequence To Patient
42
42
Extubate
31
31
No Clinical Signs, Symptoms or Conditions
29
29
Insufficient Information
10
10
Skin Tears
6
6
Death
5
5
Emotional Changes
4
4
Bruise/Contusion
4
4
Fall
3
3
Injury
3
3
No Code Available
3
3
No Patient Involvement
2
2
No Information
2
2
Confusion/ Disorientation
2
2
Bone Fracture(s)
2
2
Hemorrhage/Bleeding
1
1
Irritation
1
1
Laceration(s)
1
1
Cardiopulmonary Arrest
1
1
Anxiety
1
1
Complaint, Ill-Defined
1
1
Blood Loss
1
1
Fracture, Arm
1
1
Reinfusion
1
1
Sweating
1
1
Needle Stick/Puncture
1
1
Abrasion
1
1
Not Applicable
1
1
Unspecified Tissue Injury
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DeRoyal Industries Inc
II
Mar-30-2020
2
Queen Comfort Products lLC
II
Nov-01-2021
3
TIDI PRODUCTS
II
Oct-25-2019
-
-