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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device speculum, vaginal, nonmetal
Product CodeHIB
Regulation Number 884.4530
Device Class 2

MDR Year MDR Reports MDR Events
2019 4 4
2020 4 4
2021 4 4
2022 2 2
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Fracture 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Material Separation 2 2
Peeled/Delaminated 1 1
Detachment of Device or Device Component 1 1
Electrical /Electronic Property Problem 1 1
Device Dislodged or Dislocated 1 1
No Apparent Adverse Event 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Laceration(s) 3 3
Burn, Thermal 2 2
No Known Impact Or Consequence To Patient 2 2
No Information 1 1
No Code Available 1 1
Insufficient Information 1 1
Foreign Body In Patient 1 1
No Consequences Or Impact To Patient 1 1

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