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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device splint, hand, and components
Product CodeILH
Regulation Number 890.3475
Device Class 1

MDR Year MDR Reports MDR Events
2016 5 5
2017 8 8
2018 2 2
2019 3 3
2021 2 2
2022 1 1
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Insufficient Information 3 3
Pressure Problem 2 2
Fitting Problem 2 2
Device Operates Differently Than Expected 2 2
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Break 1 1
Fracture 1 1
Material Rupture 1 1
Use of Device Problem 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 8 8
Rash 7 7
Device Embedded In Tissue or Plaque 4 4
Swelling/ Edema 4 4
Neuralgia 3 3
Itching Sensation 2 2
Reaction 2 2
Burning Sensation 2 2
Swelling 2 2
Vomiting 1 1
Local Reaction 1 1
Peeling 1 1
Loss of Range of Motion 1 1
High Blood Pressure/ Hypertension 1 1
Inflammation 1 1
No Consequences Or Impact To Patient 1 1
Wheal(s) 1 1
Discomfort 1 1
Injury 1 1
Arthralgia 1 1
Skin Tears 1 1
Not Applicable 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 North Coast Medical Inc II Oct-19-2023
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