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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device spatula, cervical, cytological
Product CodeHHT
Regulation Number 884.4530
Device Class 2


Premarket Reviews
ManufacturerDecision
EXCELL COMPANY LLC
  SUBSTANTIALLY EQUIVALENT 1
KOLPLAST CI SA
  SUBSTANTIALLY EQUIVALENT 1
NINGBO HLS MEDICAL PRODUCTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
OTTO BOCK PUR LIFE SCIENCE GMBH
  SUBSTANTIALLY EQUIVALENT 1
PURITAN MEDICAL PRODUCTS COMPANY LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2016 6 6
2017 1 1
2018 1 1
2019 3 3
2020 3 3
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 4 4
Break 3 3
Device Dislodged or Dislocated 3 3
Difficult to Remove 2 2
Detachment Of Device Component 2 2
Device Issue 1 1
Material Fragmentation 1 1
Insufficient Information 1 1
Device Damaged Prior to Use 1 1
Patient-Device Incompatibility 1 1
Product Quality Problem 1 1
Device Fell 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 8 8
Foreign Body In Patient 4 4
No Clinical Signs, Symptoms or Conditions 3 3
No Consequences Or Impact To Patient 2 2
Discomfort 2 2
Reaction 1 1
Ambulation Difficulties 1 1
No Patient Involvement 1 1
Distress 1 1
Laceration(s) 1 1
Pain 1 1
Burning Sensation 1 1
Device Embedded In Tissue or Plaque 1 1
Syncope/Fainting 1 1

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