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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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Device
container, frozen donor tissue storage
Product Code
LPZ
Device Class
Unclassified
Premarket Reviews
Manufacturer
Decision
BIOWY CORPORATION
SUBSTANTIALLY EQUIVALENT
1
CHARTER MEDICAL, LTD.
SUBSTANTIALLY EQUIVALENT
1
MILTENYI BIOTEC, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
16
16
2017
24
24
2018
23
23
2019
7
7
2020
16
16
2021
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fracture
58
58
Material Integrity Problem
52
52
Break
45
45
Device Issue
24
24
Leak/Splash
15
15
Crack
10
10
Fluid/Blood Leak
8
8
Physical Property Issue
6
6
Material Perforation
5
5
Torn Material
3
3
Hole In Material
3
3
Device Handling Problem
2
2
Use of Device Problem
2
2
Misconnection
2
2
Therapeutic or Diagnostic Output Failure
1
1
Material Puncture/Hole
1
1
Incomplete or Missing Packaging
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Material Deformation
1
1
Stretched
1
1
Defective Device
1
1
Disconnection
1
1
Material Distortion
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Device Markings/Labelling Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
52
52
No Information
13
13
No Consequences Or Impact To Patient
12
12
No Clinical Signs, Symptoms or Conditions
5
5
No Patient Involvement
4
4
Insufficient Information
2
2
Foreign Body In Patient
1
1
No Code Available
1
1
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