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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, testicular
Regulation Description Testicular prosthesis.
Definition Call for PMAs on 7/5/95 per 60 FR 17216 on 4/5/95
Product CodeFAF
Regulation Number 876.3750
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 2 0 0 0 0

MDR Year MDR Reports MDR Events
2021 1 1
2022 1 1
2023 6 6
2024 20 20
2025 14 14
2026 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 17 17
Material Puncture/Hole 8 8
Inadequacy of Device Shape and/or Size 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Insufficient Information 2 2
Leak/Splash 1 1
Break 1 1
Malposition of Device 1 1
Device Markings/Labelling Problem 1 1
Collapse 1 1
Short Fill 1 1
Unintended Deflation 1 1
Positioning Problem 1 1
Overfill 1 1
Device Contamination with Chemical or Other Material 1 1
No Apparent Adverse Event 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 34 34
Discomfort 5 5
Unspecified Infection 4 4
Hematoma 2 2
Pain 1 1
Deformity/ Disfigurement 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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