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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, surgical instrument, disposable
Product CodeKDD
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2018 17 17
2019 22 22
2020 44 44
2021 63 63
2022 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 43 43
Break 15 15
Contamination /Decontamination Problem 11 11
Inadequate Lubrication 9 9
Device Damaged by Another Device 9 9
Output Problem 8 8
Appropriate Term/Code Not Available 6 6
Fluid/Blood Leak 6 6
Leak/Splash 6 6
Device Contamination with Chemical or Other Material 6 6
Material Integrity Problem 6 6
Detachment of Device or Device Component 5 5
Electrical /Electronic Property Problem 5 5
Insufficient Information 4 4
Contamination 4 4
Arcing 3 3
Patient-Device Incompatibility 3 3
Loss of or Failure to Bond 3 3
Mechanical Problem 3 3
Microbial Contamination of Device 2 2
Device Markings/Labelling Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Material Fragmentation 2 2
Improper or Incorrect Procedure or Method 2 2
Device Contamination with Body Fluid 1 1
Device-Device Incompatibility 1 1
Material Discolored 1 1
Product Quality Problem 1 1
Power Problem 1 1
Failure to Power Up 1 1
Material Separation 1 1
Expiration Date Error 1 1
Sparking 1 1
Fracture 1 1
Mechanical Jam 1 1
Protective Measures Problem 1 1
Delivered as Unsterile Product 1 1
Component Missing 1 1
Obstruction of Flow 1 1
Crack 1 1
Unintended Ejection 1 1
Nonstandard Device 1 1
Material Puncture/Hole 1 1
Use of Device Problem 1 1
Suction Problem 1 1
Packaging Problem 1 1
Ejection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25 25
Unspecified Infection 24 24
Fluid Discharge 24 24
No Known Impact Or Consequence To Patient 22 22
No Consequences Or Impact To Patient 12 12
Pain 12 12
Inflammation 10 10
Purulent Discharge 9 9
Wound Dehiscence 8 8
No Patient Involvement 6 6
Post Operative Wound Infection 5 5
Erythema 5 5
Fever 5 5
Insufficient Information 4 4
Impaired Healing 4 4
Device Embedded In Tissue or Plaque 4 4
Bacterial Infection 4 4
Foreign Body In Patient 4 4
No Code Available 4 4
Rash 3 3
Failure of Implant 3 3
Breast Discomfort/Pain 2 2
Itching Sensation 2 2
Not Applicable 2 2
Necrosis 2 2
Seroma 2 2
Chills 2 2
Discharge 2 2
Swelling 1 1
Local Reaction 1 1
Cellulitis 1 1
Edema 1 1
Swelling/ Edema 1 1
Nerve Damage 1 1
Discomfort 1 1
Blister 1 1
Muscle Weakness 1 1
Sweating 1 1
Decreased Sensitivity 1 1
Eye Infections 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II May-30-2018
2 Arrow International Inc II Apr-03-2018
3 Bioseal Corporation II May-20-2021
4 DeRoyal Industries Inc II May-11-2020
5 Medical Action Industries, Inc. 306 II Jun-24-2021
6 Medical Action Industries, Inc. 306 II Jan-06-2020
7 ROi Consolidated Service Center (CSC) II Aug-08-2019
8 Stryker Corporation II Mar-02-2018
9 Windstone Medical Packaging, Inc. II Jan-04-2023
10 Windstone Medical Packaging, Inc. II May-17-2022
11 Windstone Medical Packaging, Inc. II Jun-11-2021
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