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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)
2020 2021 2022 2023 2024 2025
0 0 2 0 0 0

MDR Year MDR Reports MDR Events
2020 8 8
2021 1 1
2022 1 1
2023 6 6
2024 20 20
2025 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 14 14
Inadequacy of Device Shape and/or Size 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Material Puncture/Hole 4 4
Positioning Problem 4 4
Leak/Splash 2 2
Insufficient Information 2 2
Material Deformation 2 2
Migration 2 2
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
Deflation Problem 1 1
Overfill 1 1
Device Handling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 29 29
Discomfort 5 5
Unspecified Infection 4 4
No Consequences Or Impact To Patient 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Information 2 2
Hematoma 2 2
Pain 2 2
Wound Dehiscence 1 1
Itching Sensation 1 1
Cognitive Changes 1 1
Burning Sensation 1 1
Hair Loss 1 1
Pocket Erosion 1 1

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