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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device condom, synthetic
Product CodeMOL
Regulation Number 884.5300
Device Class 2


Premarket Reviews
ManufacturerDecision
OKAMOTO U.S.A. INC.
  SUBSTANTIALLY EQUIVALENT 1
SURETEX LIMITED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 2 2
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2 2
Material Integrity Problem 2 2
Device Slipped 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Purulent Discharge 1 1
Hemorrhage/Bleeding 1 1
Muscle Weakness 1 1
Scar Tissue 1 1
Discomfort 1 1
Localized Skin Lesion 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Family Dollar Stores, Llc. II Aug-17-2022
2 Reckitt Benckiser LLC II Mar-09-2019
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