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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device diaphragm, contraceptive (and accessories)
Product CodeHDW
Regulation Number 884.5350
Device Class 2


Premarket Reviews
ManufacturerDecision
KESSEL MEDINTIM GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 1 1
2019 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Fitting Problem 3 3
Malfunction 2 2
Defective Device 1 1
Device Markings/Labelling Problem 1 1
Break 1 1
Entrapment of Device 1 1
Inadequacy of Device Shape and/or Size 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Discomfort 3 3
Other (for use when an appropriate patient code cannot be identified) 2 2
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
Pain 1 1
Urinary Tract Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cooper Surgical, Inc. II Mar-28-2013
2 CooperSurgical, Inc. II Mar-04-2016
3 CooperSurgical, Inc. II Jun-18-2015
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