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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ph buffer
Product CodeJCC
Regulation Number 864.4010
Device Class 1

MDR Year MDR Reports MDR Events
2014 103 103
2016 32 32
2017 4 4
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Contamination of Device Ingredient or Reagent 46 46
Device Contamination With Biological Material 41 41
Adverse Event Without Identified Device or Use Problem 37 37
Nonstandard Device 12 12
Fungus in Device Environment 6 6
Insufficient Information 3 3
Device Emits Odor 1 1
Precipitate in Device or Device Ingredient 1 1
Improper or Incorrect Procedure or Method 1 1
Device Operates Differently Than Expected 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 91 91
Pain 12 12
No Consequences Or Impact To Patient 9 9
Swelling 8 8
Corneal Edema 8 8
Muscle Spasm(s) 8 8
Bruise/Contusion 7 7
Numbness 5 5
Necrosis 4 4
Inflammation 3 3
Fever 3 3
Hematoma 3 3
No Information 2 2
No Code Available 1 1
Discomfort 1 1
Reaction 1 1
Unspecified Infection 1 1
Muscular Rigidity 1 1
Reaction, Injection Site 1 1
Sweating 1 1
Nasal Obstruction 1 1
Chemical Exposure 1 1
No Patient Involvement 1 1
Difficulty Chewing 1 1
Burning Sensation 1 1
Twitching 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mesa Laboratories, Inc. II Nov-07-2013
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