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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, testicular
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)
2019 2020 2021 2022 2023 2024
1 0 0 2 0 0

MDR Year MDR Reports MDR Events
2019 5 5
2020 8 8
2021 1 1
2022 1 1
2023 6 6
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 6 6
Positioning Problem 4 4
Insufficient Information 2 2
Material Deformation 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Migration 2 2
Leak/Splash 2 2
Deflation Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Patient-Device Incompatibility 1 1
Device Markings/Labelling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Break 1 1
Material Puncture/Hole 1 1
Unintended Deflation 1 1
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
No Information 5 5
No Consequences Or Impact To Patient 3 3
Unspecified Infection 2 2
Itching Sensation 1 1
Pain 1 1
Pocket Erosion 1 1
Burning Sensation 1 1
Toxicity 1 1
Cognitive Changes 1 1
Wound Dehiscence 1 1
Hair Loss 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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