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TPLC - Total Product Life Cycle
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TPLC
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Device
retractor, self-retaining
Product Code
FFO
Regulation Number
876.4730
Device Class
1
MDR Year
MDR Reports
MDR Events
2015
2
2
2016
32
32
2017
20
20
2018
2
2
2019
4
4
2020
2
2
2022
3
3
2023
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Dislodged or Dislocated
21
21
Unintended Movement
19
19
Break
12
12
Device Slipped
11
11
Mechanical Problem
6
6
Loose or Intermittent Connection
3
3
Component or Accessory Incompatibility
3
3
Device Operates Differently Than Expected
2
2
Appropriate Term/Code Not Available
1
1
Device Handling Problem
1
1
Material Too Soft/Flexible
1
1
Excessive Heating
1
1
Separation Problem
1
1
Failure to Clean Adequately
1
1
Device Contamination with Chemical or Other Material
1
1
Material Integrity Problem
1
1
Packaging Problem
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Device Maintenance Issue
1
1
Use of Device Problem
1
1
Defective Component
1
1
Component Missing
1
1
Arcing
1
1
Unsealed Device Packaging
1
1
Product Quality Problem
1
1
Shipping Damage or Problem
1
1
Device Reprocessing Problem
1
1
Contamination
1
1
Material Fragmentation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
55
55
No Consequences Or Impact To Patient
6
6
No Clinical Signs, Symptoms or Conditions
4
4
Burn(s)
1
1
Patient Problem/Medical Problem
1
1
No Information
1
1
Pregnancy
1
1
Insufficient Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abeon Medical Corporation
II
Jan-21-2016
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