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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 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 108 108
Material Integrity Problem 17 17
Appropriate Term/Code Not Available 13 13
Material Frayed 9 9
Material Perforation 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Loss of or Failure to Bond 5 5
Melted 4 4
Flaked 4 4
Fluid/Blood Leak 4 4
No Apparent Adverse Event 4 4
Break 3 3
Material Split, Cut or Torn 3 3
Physical Resistance/Sticking 2 2
Contamination 2 2
Material Discolored 2 2
Insufficient Information 2 2
Packaging Problem 2 2
Product Quality Problem 2 2
Delivered as Unsterile Product 2 2
Failure to Obtain Sample 2 2
Patient-Device Incompatibility 2 2
Contamination /Decontamination Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Contamination with Chemical or Other Material 1 1
Human-Device Interface Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Peeled/Delaminated 1 1
Difficult to Remove 1 1
Material Disintegration 1 1
Display or Visual Feedback Problem 1 1
Entrapment of Device 1 1
Crack 1 1
Difficult to Fold, Unfold or Collapse 1 1
Material Fragmentation 1 1
Nonstandard Device 1 1
Leak/Splash 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 133 133
No Known Impact Or Consequence To Patient 21 21
Insufficient Information 15 15
No Consequences Or Impact To Patient 15 15
Foreign Body In Patient 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Skin Tears 3 3
Erythema 3 3
Itching Sensation 3 3
Rash 2 2
Bruise/Contusion 2 2
Post Operative Wound Infection 2 2
Hemorrhage/Bleeding 2 2
Burning Sensation 2 2
Full thickness (Third Degree) Burn 2 2
Device Embedded In Tissue or Plaque 1 1
Blister 1 1
Skin Inflammation/ Irritation 1 1
Anaphylactic Shock 1 1
Unspecified Infection 1 1
Edema 1 1
Eye Injury 1 1
Foreign Body Sensation in Eye 1 1
Skin Discoloration 1 1
Swelling 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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