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TPLC
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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 Code
OEA
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
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Contamination /Decontamination Problem
3
3
Leak/Splash
2
2
Adverse Event Without Identified Device or Use 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
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
4
4
Insufficient Information
4
4
Hypersensitivity/Allergic reaction
2
2
Exposure to Body Fluids
2
2
High Blood Pressure/ Hypertension
1
1
Skin Irritation
1
1
Nausea
1
1
Itching Sensation
1
1
Local Reaction
1
1
No Known Impact Or Consequence To Patient
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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