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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, external penile rigidity
Definition Intended to create or maintain sufficient penile rigidity for sexual intercourse. These include vacuum pumps, constriction rings, and penile splints, which are mechanical, powered or pneumatic devices.
Product CodeLKY
Regulation Number 876.5020
Device Class 2

MDR Year MDR Reports MDR Events
2022 1 1
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Labelling, Instructions for Use or Training Problem 1 1
Structural Problem 1 1
Patient-Device Incompatibility 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Bruise/Contusion 1 1
Hematoma 1 1
Discomfort 1 1
Unspecified Tissue Injury 1 1

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