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
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
Device
passer
Product Code
HWQ
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
64
64
2019
55
55
2020
171
171
2021
160
160
2022
63
63
2023
49
49
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
311
311
Material Separation
53
53
Detachment of Device or Device Component
39
39
Mechanical Jam
31
31
Mechanical Problem
17
17
Failure to Advance
14
14
Adverse Event Without Identified Device or Use Problem
11
11
Fracture
10
10
Physical Resistance/Sticking
9
9
Material Integrity Problem
8
8
Material Deformation
7
7
Detachment Of Device Component
7
7
Insufficient Information
6
6
Material Split, Cut or Torn
5
5
Device Dislodged or Dislocated
5
5
Device Operates Differently Than Expected
5
5
Material Fragmentation
5
5
Misassembled
5
5
Delivered as Unsterile Product
4
4
Difficult to Open or Close
4
4
Ejection Problem
4
4
Firing Problem
4
4
Device Fell
4
4
No Apparent Adverse Event
4
4
Failure to Fire
3
3
Device-Device Incompatibility
3
3
Nonstandard Device
3
3
Device Damaged Prior to Use
3
3
Bent
3
3
Positioning Failure
3
3
Entrapment of Device
3
3
Failure to Cycle
2
2
Difficult to Insert
2
2
Separation Failure
2
2
Device Contamination with Chemical or Other Material
2
2
Activation, Positioning or Separation Problem
2
2
Difficult to Open or Remove Packaging Material
2
2
Activation Problem
2
2
Separation Problem
2
2
Inaccurate Information
1
1
Appropriate Term/Code Not Available
1
1
Migration
1
1
Output Problem
1
1
Unintended Movement
1
1
Device Operational Issue
1
1
Device Disinfection Or Sterilization Issue
1
1
Installation-Related Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Twisted/Bent
1
1
Defective Device
1
1
Expiration Date Error
1
1
Misfire
1
1
Solder Joint Fracture
1
1
Failure to Align
1
1
Unsealed Device Packaging
1
1
Product Quality Problem
1
1
Retraction Problem
1
1
Problem with Sterilization
1
1
Unstable
1
1
Use of Device Problem
1
1
Loose or Intermittent Connection
1
1
Melted
1
1
Grounding Malfunction
1
1
Flaked
1
1
Difficult to Fold, Unfold or Collapse
1
1
Component Falling
1
1
Crack
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
295
295
No Known Impact Or Consequence To Patient
176
176
No Consequences Or Impact To Patient
36
36
Foreign Body In Patient
22
22
No Information
19
19
No Patient Involvement
9
9
Device Embedded In Tissue or Plaque
8
8
Insufficient Information
7
7
Injury
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Hypersensitivity/Allergic reaction
2
2
Failure of Implant
1
1
Unspecified Infection
1
1
Pain
1
1
Scar Tissue
1
1
Tissue Damage
1
1
Chills
1
1
Rupture
1
1
No Code Available
1
1
-
-