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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device drape, surgical, exempt
Definition This product code is the class II exempt counterpart of KKX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 878.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Product CodePUI
Regulation Number 878.4370
Device Class 2

MDR Year MDR Reports MDR Events
2020 17 17
2021 43 43
2022 47 47
2023 46 46
2024 69 69

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 117 117
Material Integrity Problem 13 13
Loss of or Failure to Bond 8 8
Contamination 8 8
Material Perforation 7 7
Product Quality Problem 6 6
Adverse Event Without Identified Device or Use Problem 6 6
No Apparent Adverse Event 5 5
Fluid/Blood Leak 4 4
Flaked 4 4
Material Separation 4 4
Break 3 3
Melted 3 3
Material Discolored 3 3
Packaging Problem 2 2
Delivered as Unsterile Product 2 2
Material Fragmentation 2 2
Insufficient Information 2 2
Patient-Device Incompatibility 2 2
Material Disintegration 2 2
Material Split, Cut or Torn 2 2
Leak/Splash 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Unsealed Device Packaging 1 1
Difficult to Remove 1 1
Contamination /Decontamination Problem 1 1
Difficult to Fold, Unfold or Collapse 1 1
Peeled/Delaminated 1 1
Crack 1 1
Accessory Incompatible 1 1
Physical Resistance/Sticking 1 1
Device Contamination with Chemical or Other Material 1 1
Failure to Eject 1 1
Fracture 1 1
Gel Leak 1 1
Difficult to Open or Remove Packaging Material 1 1
Nonstandard Device 1 1
Human-Device Interface Problem 1 1
Display or Visual Feedback Problem 1 1
Entrapment of Device 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 173 173
Insufficient Information 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
No Known Impact Or Consequence To Patient 4 4
No Consequences Or Impact To Patient 4 4
Foreign Body Sensation in Eye 3 3
Itching Sensation 3 3
Erythema 3 3
Skin Tears 3 3
Hypersensitivity/Allergic reaction 2 2
Burning Sensation 2 2
Rash 2 2
Hemorrhage/Bleeding 2 2
Full thickness (Third Degree) Burn 2 2
Bruise/Contusion 2 2
Unspecified Infection 1 1
Skin Inflammation/ Irritation 1 1
Edema 1 1
Blister 1 1
Skin Discoloration 1 1
Post Operative Wound Infection 1 1
Foreign Body In Patient 1 1
Swelling 1 1
No Patient Involvement 1 1
Eye Injury 1 1
Anaphylactic Shock 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 3M Healthcare Business II Nov-18-2022
2 Aesculap Implant Systems LLC II Jul-22-2022
3 Cardinal Health 200, LLC II Jul-08-2021
4 Cardinal Health 200, LLC II Mar-24-2021
5 Ecolab Inc II Feb-22-2021
6 Microtek Medical Inc. II Jul-28-2023
7 Microtek Medical Inc. II May-12-2022
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