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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
IBI ISRAEL BIOMEDICAL INNOVATIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEOMEDIC INTERNATIONAL S.L.
  SUBSTANTIALLY EQUIVALENT 1
POP MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2022 2 2
2023 34 34
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 30 30
Adverse Event Without Identified Device or Use Problem 3 3
Appropriate Term/Code Not Available 1 1
Material Twisted/Bent 1 1
Patient Device Interaction Problem 1 1
Material Erosion 1 1
Break 1 1
Implant extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 31 31
Pain 4 4
Prolapse 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Urinary Retention 1 1
Other (for use when an appropriate patient code cannot be identified) 1 1
Discomfort 1 1
Surgical procedure 1 1
Erosion 1 1
Extrusion 1 1
Micturition Urgency 1 1
Hematoma 1 1
Incontinence 1 1
Unspecified Infection 1 1

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