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TPLC
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Device
polymer, ent synthetic-polyamide (mesh or foil material)
Product Code
KHJ
Regulation Number
874.3620
Device Class
2
Premarket Reviews
Manufacturer
Decision
CEREMED, INC.
SUBSTANTIALLY EQUIVALENT
4
COOK BIOTECH INCORPORATED
SUBSTANTIALLY EQUIVALENT
2
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
Expiration Date Error
2
2
Insufficient Information
2
2
Device Appears to Trigger Rejection
2
2
Patient-Device Incompatibility
1
1
Patient Device Interaction Problem
1
1
Product Quality Problem
1
1
Appropriate Term/Code Not Available
1
1
Degraded
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
2
2
Local Reaction
2
2
Pain
2
2
Dysphagia/ Odynophagia
2
2
Dysphasia
1
1
Urticaria
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Apnea
1
1
Respiratory Distress
1
1
Fatigue
1
1
Hearing Loss
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Malaise
1
1
Perforation
1
1
Edema
1
1
Itching Sensation
1
1
Overdose
1
1
Fever
1
1
Paralysis
1
1
Erythema
1
1
Insufficient Information
1
1
Dyspnea
1
1
Paresis
1
1
Partial Hearing Loss
1
1
Reaction
1
1
Tachycardia
1
1
Swelling/ Edema
1
1
Therapeutic Effects, Unexpected
1
1
Airway Obstruction
1
1
Granuloma
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Merz North America, Inc.
II
Dec-03-2015
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