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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device kit, surgical instrument, disposable
Product CodeKDD
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 22 22
2020 44 44
2021 63 63
2022 12 12
2023 43 43
2024 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Inadequate Lubrication 46 46
Adverse Event Without Identified Device or Use Problem 43 43
Break 19 19
Contamination /Decontamination Problem 12 12
Device Damaged by Another Device 10 10
Material Integrity Problem 9 9
Output Problem 8 8
Appropriate Term/Code Not Available 7 7
Expiration Date Error 5 5
Fluid/Blood Leak 5 5
Leak/Splash 4 4
Device Contamination with Chemical or Other Material 4 4
Contamination 4 4
Electrical /Electronic Property Problem 4 4
Delivered as Unsterile Product 3 3
Loss of or Failure to Bond 3 3
Patient-Device Incompatibility 3 3
Inaccurate Information 3 3
Material Fragmentation 2 2
Arcing 2 2
Detachment of Device or Device Component 2 2
Insufficient Information 2 2
Packaging Problem 2 2
Microbial Contamination of Device 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Markings/Labelling Problem 2 2
Product Quality Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Tear, Rip or Hole in Device Packaging 1 1
Device Contamination with Body Fluid 1 1
Power Problem 1 1
Fracture 1 1
Sparking 1 1
Suction Problem 1 1
Unintended Ejection 1 1
Obstruction of Flow 1 1
Material Puncture/Hole 1 1
Use of Device Problem 1 1
Component Missing 1 1
Entrapment of Device 1 1
Ejection Problem 1 1
Mechanical Problem 1 1
Crack 1 1
Nonstandard Device 1 1
Device-Device Incompatibility 1 1
Peeled/Delaminated 1 1
Device Contaminated During Manufacture or Shipping 1 1
Failure to Power Up 1 1
Off-Label Use 1 1
Mechanical Jam 1 1
Protective Measures Problem 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 74 74
Unspecified Infection 24 24
Fluid Discharge 23 23
Failure of Implant 19 19
No Known Impact Or Consequence To Patient 12 12
Pain 12 12
No Consequences Or Impact To Patient 11 11
Inflammation 9 9
Wound Dehiscence 8 8
Purulent Discharge 8 8
Insufficient Information 7 7
Foreign Body In Patient 6 6
Erythema 5 5
Fever 5 5
Impaired Healing 4 4
No Code Available 4 4
Post Operative Wound Infection 4 4
No Patient Involvement 4 4
Device Embedded In Tissue or Plaque 3 3
Bacterial Infection 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Breast Discomfort/Pain 2 2
Necrosis 2 2
Rash 2 2
Seroma 2 2
Not Applicable 2 2
Discharge 2 2
Chills 2 2
Discomfort 1 1
Tissue Breakdown 1 1
Decreased Sensitivity 1 1
Eye Infections 1 1
Unspecified Gastrointestinal Problem 1 1
Sweating 1 1
Swelling 1 1
Local Reaction 1 1
Nerve Damage 1 1
Cellulitis 1 1
Edema 1 1
Itching Sensation 1 1
Muscle Weakness 1 1
Blister 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beaver Visitec International, Inc. II Mar-01-2023
2 Bioseal Corporation II May-20-2021
3 DeRoyal Industries Inc II Jul-03-2023
4 DeRoyal Industries Inc II May-11-2020
5 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
6 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
7 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
9 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
10 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
11 Medical Action Industries, Inc. 306 II Jun-24-2021
12 Medical Action Industries, Inc. 306 II Jan-06-2020
13 ROi Consolidated Service Center (CSC) II Aug-08-2019
14 Stryker Corporation II Nov-09-2023
15 Windstone Medical Packaging, Inc. I Feb-16-2024
16 Windstone Medical Packaging, Inc. II May-23-2023
17 Windstone Medical Packaging, Inc. II Jan-04-2023
18 Windstone Medical Packaging, Inc. II May-17-2022
19 Windstone Medical Packaging, Inc. II Jun-11-2021
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