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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cover, limb
Product CodeIPM
Regulation Number 890.3025
Device Class 1

MDR Year MDR Reports MDR Events
2015 2 2
2016 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2 2
Material Separation 1 1
Patient-Device Incompatibility 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Irritation 1 1
Local Reaction 1 1
Skin Irritation 1 1
Tissue Damage 1 1
Skin Inflammation 1 1
No Known Impact Or Consequence To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 WillowWood Global Llc II May-14-2021
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