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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 polymer, ent synthetic-polyamide (mesh or foil material)
Product CodeKHJ
Regulation Number 874.3620
Device Class 2

MDR Year MDR Reports MDR Events
2018 4 4
2019 2 2
2020 1 1
2021 1 1
2022 3 3
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Device Appears to Trigger Rejection 2 2
Expiration Date Error 2 2
Degraded 1 1
Product Quality Problem 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Local Reaction 2 2
Therapeutic Effects, Unexpected 1 1
No Code Available 1 1
Partial Hearing Loss 1 1
Swelling/ Edema 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Apnea 1 1
Granuloma 1 1
Hearing Loss 1 1
Overdose 1 1
Pain 1 1
Paralysis 1 1
Perforation 1 1

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