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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
2019 3 3
2021 2 2
2022 1 1
2023 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Fitting Problem 2 2
Pressure Problem 2 2
Insufficient Information 1 1
Patient-Device Incompatibility 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 5 5
Device Embedded In Tissue or Plaque 4 4
Swelling/ Edema 4 4
Neuralgia 3 3
High Blood Pressure/ Hypertension 1 1
Inflammation 1 1
Itching Sensation 1 1
Loss of Range of Motion 1 1
Vomiting 1 1
Burning Sensation 1 1
Injury 1 1
Arthralgia 1 1
Reaction 1 1
Skin Tears 1 1

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