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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wound dressing kit
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeMCY
Regulation Number 880.5075
Device Class 2

MDR Year MDR Reports MDR Events
2020 9 9
2021 3 3
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3 3
Insufficient Information 3 3
Leak/Splash 2 2
Crack 2 2
Defective Component 2 2
Loose or Intermittent Connection 2 2
Physical Resistance/Sticking 1 1
Patient-Device Incompatibility 1 1
Material Integrity Problem 1 1
Contamination /Decontamination Problem 1 1
Component Missing 1 1
Device Appears to Trigger Rejection 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Blister 3 3
Rash 3 3
Unspecified Infection 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Impaired Healing 2 2
Hypersensitivity/Allergic reaction 2 2
Abrasion 2 2
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 2 2
No Code Available 1 1
Foreign Body In Patient 1 1
Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Busse Hospital Disposables, Inc. I Jan-03-2024
2 Busse Hospital Disposables, Inc. II May-28-2022
3 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
4 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
5 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
6 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Nov-16-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
9 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
10 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
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