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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
2019 28 28
2020 17 17
2021 43 43
2022 47 47
2023 46 46
2024 52 52

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 117 117
Material Integrity Problem 18 18
Appropriate Term/Code Not Available 13 13
Material Frayed 9 9
Loss of or Failure to Bond 8 8
Material Perforation 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Product Quality Problem 5 5
No Apparent Adverse Event 5 5
Contamination 4 4
Melted 4 4
Flaked 4 4
Fluid/Blood Leak 4 4
Material Split, Cut or Torn 3 3
Break 3 3
Insufficient Information 3 3
Material Discolored 3 3
Material Separation 3 3
Leak/Splash 2 2
Physical Resistance/Sticking 2 2
Material Disintegration 2 2
Patient-Device Incompatibility 2 2
Failure to Obtain Sample 2 2
Material Fragmentation 2 2
Delivered as Unsterile Product 2 2
Packaging Problem 2 2
Entrapment of Device 1 1
Difficult to Open or Remove Packaging Material 1 1
Crack 1 1
Peeled/Delaminated 1 1
Difficult to Fold, Unfold or Collapse 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Remove 1 1
Contamination /Decontamination Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Gel Leak 1 1
Nonstandard Device 1 1
Human-Device Interface Problem 1 1
Display or Visual Feedback Problem 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 158 158
No Known Impact Or Consequence To Patient 21 21
Insufficient Information 16 16
No Consequences Or Impact To Patient 16 16
Foreign Body In Patient 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Foreign Body Sensation in Eye 3 3
Itching Sensation 3 3
Erythema 3 3
Skin Tears 3 3
Post Operative Wound Infection 2 2
Rash 2 2
Burning Sensation 2 2
Hemorrhage/Bleeding 2 2
Full thickness (Third Degree) Burn 2 2
Bruise/Contusion 2 2
Unspecified Infection 1 1
Hypersensitivity/Allergic reaction 1 1
Skin Inflammation/ Irritation 1 1
Edema 1 1
Blister 1 1
Skin Discoloration 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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