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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
2017 12 12
2018 17 17
2019 22 22
2020 44 44
2021 63 63
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 42 42
Break 15 15
Contamination /Decontamination Problem 11 11
Device Damaged by Another Device 9 9
Inadequate Lubrication 9 9
Output Problem 8 8
Device Contamination with Chemical or Other Material 7 7
Fluid Leak 6 6
Leak/Splash 6 6
Electrical /Electronic Property Problem 5 5
Detachment of Device or Device Component 5 5
Patient-Device Incompatibility 5 5
Material Integrity Problem 5 5
Appropriate Term/Code Not Available 5 5
Insufficient Information 4 4
Material Fragmentation 4 4
Contamination 4 4
Mechanical Problem 3 3
Loss of or Failure to Bond 3 3
Arcing 3 3
Device Packaging Compromised 2 2
Improper or Incorrect Procedure or Method 2 2
Microbial Contamination of Device 2 2
Fracture 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Mechanical Jam 1 1
Packaging Problem 1 1
Power Problem 1 1
Protective Measures Problem 1 1
Ejection Problem 1 1
Unintended Ejection 1 1
Crack 1 1
Material Discolored 1 1
Detachment Of Device Component 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Failure to Power Up 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Material Separation 1 1
Shelf Life Exceeded 1 1
Use of Device Problem 1 1
Component Missing 1 1
Device Contamination with Body Fluid 1 1
Expiration Date Error 1 1
Suction Problem 1 1
Device-Device Incompatibility 1 1
Device Contaminated During Manufacture or Shipping 1 1
Sparking 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 25 25
No Known Impact Or Consequence To Patient 25 25
Fluid Discharge 24 24
No Clinical Signs, Symptoms or Conditions 23 23
Pain 14 14
No Consequences Or Impact To Patient 13 13
Inflammation 10 10
Purulent Discharge 9 9
Wound Dehiscence 8 8
Device Embedded In Tissue or Plaque 7 7
No Patient Involvement 6 6
Post Operative Wound Infection 5 5
Bacterial Infection 5 5
Fever 5 5
Impaired Healing 4 4
Erythema 4 4
No Code Available 4 4
Insufficient Information 4 4
Discomfort 3 3
Failure of Implant 3 3
Rash 3 3
Seroma 2 2
Swelling 2 2
Chills 2 2
Itching Sensation 2 2
Necrosis 2 2
Discharge 2 2
Not Applicable 2 2
No Information 1 1
Eye Infections 1 1
Breast Discomfort/Pain 1 1
Blister 1 1
Swelling/ Edema 1 1
Peritonitis 1 1
Sweating 1 1
Abdominal Distention 1 1
Cellulitis 1 1
Edema 1 1
Local Reaction 1 1
Scar Tissue 1 1
Foreign Body In Patient 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 Bioseal Corporation II Nov-09-2017
5 DeRoyal Industries Inc II May-11-2020
6 Medical Action Industries, Inc. 306 II Jun-24-2021
7 Medical Action Industries, Inc. 306 II Jan-06-2020
8 ROi Consolidated Service Center (CSC) II Aug-08-2019
9 Stryker Corporation II Mar-02-2018
10 Windstone Medical Packaging, Inc. II May-17-2022
11 Windstone Medical Packaging, Inc. II Jun-11-2021
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