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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 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Material Puncture/Hole 95 95
Material Integrity Problem 14 14
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
No Apparent Adverse Event 4 4
Melted 4 4
Fluid/Blood Leak 3 3
Loss of or Failure to Bond 3 3
Break 3 3
Material Split, Cut or Torn 3 3
Physical Resistance/Sticking 2 2
Insufficient Information 2 2
Packaging Problem 2 2
Product Quality Problem 2 2
Failure to Obtain Sample 2 2
Patient-Device Incompatibility 2 2
Contamination 2 2
Material Discolored 2 2
Delivered as Unsterile Product 2 2
Peeled/Delaminated 1 1
Nonstandard Device 1 1
Difficult to Fold, Unfold or Collapse 1 1
Material Fragmentation 1 1
Loose or Intermittent Connection 1 1
Material Disintegration 1 1
Entrapment of Device 1 1
Flaked 1 1
Crack 1 1
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
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 117 117
No Known Impact Or Consequence To Patient 21 21
No Consequences Or Impact To Patient 15 15
Insufficient Information 14 14
Foreign Body In Patient 8 8
Erythema 3 3
Itching Sensation 3 3
Skin Tears 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hemorrhage/Bleeding 2 2
Bruise/Contusion 2 2
Rash 2 2
Post Operative Wound Infection 2 2
Burning Sensation 2 2
Full thickness (Third Degree) Burn 2 2
Skin Discoloration 1 1
Swelling 1 1
Unspecified Infection 1 1
Blister 1 1
Device Embedded In Tissue or Plaque 1 1
Edema 1 1
Foreign Body Sensation in Eye 1 1
Anaphylactic Shock 1 1
Skin Inflammation/ Irritation 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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