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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
Regulation Description Surgical apparel.
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
2020 6 7
2021 3 3
2022 1 1
2023 1 1
2024 8 8
2025 1 1

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 4 5
Hypersensitivity/Allergic reaction 2 2
Exposure to Body Fluids 2 2
High Blood Pressure/ Hypertension 1 1
Nausea 1 1
Itching Sensation 1 1
Local Reaction 1 1
Burn(s) 1 1
No Patient Involvement 1 1
Pain 1 1
Reaction 1 1
Nodule 1 1
Swelling/ Edema 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
4 Stryker Corporation II Jul-03-2024
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