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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 Operates Differently Than Expected 1 1
Device Contamination with Chemical or Other Material 1 1
Device Emits Odor 1 1
Improper or Incorrect Procedure or Method 1 1
Precipitate in Device or Device Ingredient 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
Muscle Spasm(s) 8 8
Swelling 8 8
Corneal Edema 8 8
Bruise/Contusion 7 7
Numbness 5 5
Necrosis 4 4
Hematoma 3 3
Inflammation 3 3
Fever 3 3
No Information 2 2
Unspecified Infection 1 1
Sweating 1 1
No Code Available 1 1
Reaction, Injection Site 1 1
Chemical Exposure 1 1
Burning Sensation 1 1
Muscular Rigidity 1 1
Twitching 1 1
Discomfort 1 1
No Patient Involvement 1 1
Reaction 1 1
Nasal Obstruction 1 1
Difficulty Chewing 1 1

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