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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device speculum, vaginal, nonmetal
Regulation Description Obstetric-gynecologic specialized manual instrument.
Product CodeHIB
Regulation Number 884.4530
Device Class 2

MDR Year MDR Reports MDR Events
2017 5 5
2018 3 3
2019 4 4
2020 4 4
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5 5
Fracture 5 5
Adverse Event Without Identified Device or Use Problem 2 2
Physical Property Issue 1 1
No Apparent Adverse Event 1 1
Peeled/Delaminated 1 1
Material Separation 1 1
Device Dislodged or Dislocated 1 1
Detachment Of Device Component 1 1
Crack 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
Burn, Thermal 2 2
Laceration(s) 2 2
No Code Available 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Corneal Abrasion 1 1
Pain 1 1
Vaginal Mucosa Damage 1 1
No Consequences Or Impact To Patient 1 1
Discomfort 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
No Information 1 1

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