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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device non-surgical gown
Definition A gown intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material
Product CodeOEA
Regulation Number 878.4040
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 6 6
2021 3 3
2022 1 1
2023 1 1
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination /Decontamination Problem 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Protective Measures Problem 2 2
Leak/Splash 2 2
Product Quality Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Device Contamination with Body Fluid 1 1
Patient-Device Incompatibility 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 4 4
No Clinical Signs, Symptoms or Conditions 3 3
Hypersensitivity/Allergic reaction 2 2
Itching Sensation 1 1
Pain 1 1
Skin Irritation 1 1
Reaction 1 1
No Patient Involvement 1 1
No Known Impact Or Consequence To Patient 1 1
Nodule 1 1
Swelling/ Edema 1 1
Exposure to Body Fluids 1 1
Burn(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardinal Health 200, LLC II Feb-05-2021
2 ROi CPS LLC II Jun-26-2020
3 Sobel Westex II Oct-22-2020
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