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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device curette, uterine
Product CodeHCY
Regulation Number 884.4530
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 2 2
2022 4 4
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4 4
Material Fragmentation 3 3
Fracture 2 2
Material Separation 1 1
Shipping Damage or Problem 1 1
Device Damaged Prior to Use 1 1
Patient-Device Incompatibility 1 1
Detachment of Device or Device Component 1 1
Material Integrity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Foreign Body In Patient 3 3
Insufficient Information 1 1
Abdominal Pain 1 1
Abrasion 1 1
Laceration(s) 1 1
Perforation 1 1
Rash 1 1
No Consequences Or Impact To Patient 1 1
Abdominal Distention 1 1

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