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TPLC
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show TPLC since
2008
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2023
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Device
expander, surgical, skin graft
Product Code
FZW
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
480
480
2019
468
468
2020
486
486
2021
554
554
2022
510
510
2023
494
494
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Cut
1677
1677
Material Twisted/Bent
692
692
Physical Resistance/Sticking
274
274
Appropriate Term/Code Not Available
124
124
Mechanical Jam
86
86
Material Deformation
82
82
Mechanical Problem
70
70
Bent
61
61
Naturally Worn
59
59
Difficult to Remove
47
47
Break
37
37
Dull, Blunt
30
30
Patient Device Interaction Problem
30
30
Calibration Problem
21
21
Insufficient Information
20
20
Component Missing
17
17
Material Integrity Problem
16
16
Device Operates Differently Than Expected
14
14
Output Problem
13
13
Difficult to Advance
13
13
Fitting Problem
12
12
Device Damaged Prior to Use
10
10
Activation, Positioning or Separation Problem
10
10
Material Too Rigid or Stiff
9
9
Positioning Problem
7
7
Material Split, Cut or Torn
7
7
Activation Failure
5
5
No Apparent Adverse Event
5
5
Difficult to Open or Close
5
5
Failure to Align
5
5
Expiration Date Error
5
5
Loose or Intermittent Connection
5
5
Defective Component
5
5
Degraded
5
5
Material Discolored
5
5
Electrical /Electronic Property Problem
4
4
Difficult To Position
4
4
Defective Device
4
4
Detachment of Device or Device Component
4
4
Dent in Material
4
4
Connection Problem
4
4
Packaging Problem
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Activation Problem
4
4
Failure to Disconnect
3
3
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Device Slipped
3
3
Sticking
3
3
Disassembly
3
3
Misassembled
3
3
Corroded
3
3
Crack
2
2
Fracture
2
2
Structural Problem
2
2
Loss of Power
2
2
Incorrect Measurement
2
2
Failure to Advance
2
2
Contamination /Decontamination Problem
2
2
Failure to Clean Adequately
2
2
Illegible Information
1
1
Device Fell
1
1
Intermittent Loss of Power
1
1
Ejection Problem
1
1
Device Handling Problem
1
1
Free or Unrestricted Flow
1
1
Gas/Air Leak
1
1
Operating System Becomes Nonfunctional
1
1
Mechanics Altered
1
1
Device Damaged by Another Device
1
1
Power Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Misassembly by Users
1
1
Device Difficult to Maintain
1
1
Failure to Power Up
1
1
Shipping Damage or Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Labelling, Instructions for Use or Training Problem
1
1
Flaked
1
1
No Device Output
1
1
Peeled/Delaminated
1
1
Positioning Failure
1
1
Detachment Of Device Component
1
1
Contamination
1
1
Partial Blockage
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1479
1479
No Patient Involvement
597
597
No Consequences Or Impact To Patient
506
506
No Known Impact Or Consequence To Patient
353
353
Abrasion
70
70
Insufficient Information
34
34
No Code Available
31
31
No Information
24
24
Laceration(s)
21
21
Tissue Damage
5
5
Injury
4
4
Skin Tears
1
1
Oversedation
1
1
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