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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fixation, non-absorbable or absorbable, for pelvic use
Definition Attaching suture or stapling ligaments of the pelvic floor.
Product CodePBQ
Regulation Number 884.4530
Device Class 2


Premarket Reviews
ManufacturerDecision
COLOPLAST A/S
  SUBSTANTIALLY EQUIVALENT 1
ESCALA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2022 2 2
2023 34 34
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 39 39
Material Deformation 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1
Break 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 40 40
Pain 2 2
Prolapse 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hematoma 1 1
Insufficient Information 1 1
Neuralgia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 FEMSelect Ltd II Feb-02-2022
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