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U.S. Department of Health and Human Services

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


Premarket Reviews
ManufacturerDecision
CEREMED, INC.
  SUBSTANTIALLY EQUIVALENT 4
COOK BIOTECH INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COOK BIOTECH INCORPRATED
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 2 2
2015 1 1
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
Insufficient Information 2 2
Device Appears to Trigger Rejection 2 2
Expiration Date Error 2 2
Patient-Device Incompatibility 1 1
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
Dysphagia/ Odynophagia 2 2
Local Reaction 2 2
Pain 2 2
No Code Available 2 2
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
Paralysis 1 1
Paresis 1 1
Perforation 1 1
Airway Obstruction 1 1
Apnea 1 1
Respiratory Distress 1 1
Tachycardia 1 1
Therapeutic Effects, Unexpected 1 1
Dysphasia 1 1
Urticaria 1 1
Malaise 1 1
Reaction 1 1
Dyspnea 1 1
Edema 1 1
Erythema 1 1
Fatigue 1 1
Fever 1 1
Granuloma 1 1
Hearing Loss 1 1
Itching Sensation 1 1
Overdose 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Merz North America, Inc. II Dec-03-2015
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