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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, ureteral, gastro-urology
Product CodeEYB
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT - KIT 2
DORNIER MEDTECH AMERICA INC
  SUBSTANTIALLY EQUIVALENT 1
PROMEPAL SAM
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 22 22
2020 13 13
2021 11 11
2022 5 5
2023 23 23
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 19 19
Material Puncture/Hole 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Incorrect Measurement 6 6
Inflation Problem 5 5
Device Contaminated During Manufacture or Shipping 5 5
Material Twisted/Bent 4 4
Deflation Problem 4 4
Material Fragmentation 4 4
Inaccurate Flow Rate 3 3
Device Markings/Labelling Problem 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Patient Device Interaction Problem 2 2
Break 2 2
Material Separation 2 2
Leak/Splash 2 2
Nonstandard Device 2 2
Defective Component 2 2
Obstruction of Flow 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1
Deformation Due to Compressive Stress 1 1
Contamination /Decontamination Problem 1 1
Fitting Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Misassembled 1 1
Material Split, Cut or Torn 1 1
Device Fell 1 1
Wrong Label 1 1
Material Deformation 1 1
Difficult to Advance 1 1
No Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 34 34
No Consequences Or Impact To Patient 21 21
No Known Impact Or Consequence To Patient 14 14
No Patient Involvement 2 2
Foreign Body In Patient 2 2
Laceration(s) 2 2
Pain 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Rash 1 1
Fever 1 1
Unspecified Infection 1 1
Discomfort 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
No Code Available 1 1
Renal Impairment 1 1
Kidney Infection 1 1
Blister 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hobbs Medical, Inc. II Oct-07-2022
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