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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 6 6

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 9 9
Improper or Incorrect Procedure or Method 7 7
Material Integrity Problem 7 7
Device Operates Differently Than Expected 5 5
Leak/Splash 3 3
Air Leak 3 3
Deflation Problem 3 3
Hole In Material 2 2
Collapse 2 2
Crack 2 2
Device Slipped 2 2
Material Deformation 2 2
Device Difficult to Maintain 2 2
Material Split, Cut or Torn 2 2
Appropriate Term/Code Not Available 1 1
Explosion 1 1
Inadequate Storage 1 1
Device Inoperable 1 1
Inadequate User Interface 1 1
Mechanics Altered 1 1
Protective Measures Problem 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Bent 1 1
Loss of or Failure to Bond 1 1
Burst Container or Vessel 1 1
Mechanical Problem 1 1
Unintended Collision 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Fitting Problem 1 1
Component Missing 1 1
Device Issue 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pressure Sores 48 48
No Known Impact Or Consequence To Patient 24 24
No Information 7 7
No Consequences Or Impact To Patient 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Insufficient Information 3 3
Tissue Breakdown 3 3
Injury 3 3
Unspecified Infection 2 2
Laceration(s) 1 1
Pain 1 1
Respiratory Distress 1 1
Tissue Damage 1 1
Ulceration 1 1
Cyanosis 1 1
Fall 1 1
Bone Fracture(s) 1 1
Hematoma 1 1
Hip Fracture 1 1
Disability 1 1
Patient Problem/Medical Problem 1 1
No Code Available 1 1

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