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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cushion, flotation
Product CodeKIC
Regulation Number 890.3175
Device Class 1

MDR Year MDR Reports MDR Events
2014 13 13
2015 31 31
2016 2 2
2017 5 5
2018 7 7
2019 8 8
2020 4 4
2021 12 12
2022 6 6
2023 12 12
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 21 21
Adverse Event Without Identified Device or Use Problem 10 10
Break 10 10
Use of Device Problem 10 10
Improper or Incorrect Procedure or Method 7 7
Material Integrity Problem 7 7
Device Operates Differently Than Expected 5 5
Air Leak 3 3
Leak/Splash 3 3
Deflation Problem 3 3
Crack 2 2
Collapse 2 2
Device Slipped 2 2
Material Split, Cut or Torn 2 2
Device Difficult to Maintain 2 2
Material Deformation 2 2
Hole In Material 2 2
Mechanics Altered 1 1
Explosion 1 1
Inadequacy of Device Shape and/or Size 1 1
Product Quality Problem 1 1
Device Issue 1 1
Inadequate Storage 1 1
Material Puncture/Hole 1 1
Patient-Device Incompatibility 1 1
Defective Device 1 1
Fitting Problem 1 1
Burst Container or Vessel 1 1
Mechanical Problem 1 1
Component Missing 1 1
Bent 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Appropriate Term/Code Not Available 1 1
Protective Measures Problem 1 1
Device Inoperable 1 1
Unintended Collision 1 1
Inadequate User Interface 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pressure Sores 49 49
No Known Impact Or Consequence To Patient 24 24
No Information 7 7
No Clinical Signs, Symptoms or Conditions 6 6
No Consequences Or Impact To Patient 4 4
Injury 3 3
Insufficient Information 3 3
Tissue Breakdown 3 3
Unspecified Infection 2 2
Cyanosis 1 1
Patient Problem/Medical Problem 1 1
Hip Fracture 1 1
Respiratory Distress 1 1
No Code Available 1 1
Disability 1 1
Bone Fracture(s) 1 1
Hematoma 1 1
Cellulitis 1 1
Fall 1 1
Laceration(s) 1 1
Pain 1 1
Ulceration 1 1
Tissue Damage 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Roho Inc. II Apr-05-2017
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