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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gauge, depth
Regulation Description Depth gauge for clinical use.
Product CodeHTJ
Regulation Number 888.4300
Device Class 1

MDR Year MDR Reports MDR Events
2020 354 354
2021 403 404
2022 316 318
2023 376 377
2024 371 371
2025 407 408

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1238 1239
Material Deformation 589 593
Mechanical Jam 130 130
Device-Device Incompatibility 93 93
Incorrect Measurement 61 61
Use of Device Problem 44 44
Fracture 37 38
Material Twisted/Bent 34 34
Detachment of Device or Device Component 29 29
Material Integrity Problem 27 27
Mechanical Problem 24 24
Illegible Information 23 23
Naturally Worn 21 21
Material Discolored 19 19
Device Slipped 15 15
No Apparent Adverse Event 11 11
Crack 10 10
Component Missing 9 9
Appropriate Term/Code Not Available 9 9
Entrapment of Device 8 8
Corroded 6 6
Defective Device 5 5
Degraded 4 4
Failure to Cut 4 4
Tear, Rip or Hole in Device Packaging 4 4
Contamination /Decontamination Problem 3 3
Device Damaged Prior to Use 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Device Markings/Labelling Problem 2 2
Physical Resistance/Sticking 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Unintended Movement 1 1
Failure to Clean Adequately 1 1
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Scratched Material 1 1
Material Fragmentation 1 1
Separation Failure 1 1
Misassembled 1 1
Output Problem 1 1
Material Separation 1 1
Component Misassembled 1 1
Fitting Problem 1 1
Device Dislodged or Dislocated 1 1
Disconnection 1 1
Improper or Incorrect Procedure or Method 1 1
Dull, Blunt 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1818 1823
No Consequences Or Impact To Patient 176 176
No Patient Involvement 116 116
Insufficient Information 107 107
Foreign Body In Patient 10 10
No Code Available 5 5
No Known Impact Or Consequence To Patient 4 4
Not Applicable 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pneumothorax 1 1
Failure of Implant 1 1
Bone Fracture(s) 1 1
Injury 1 1
Laceration(s) 1 1
Unspecified Tissue Injury 1 1
Bacterial Infection 1 1
Hemorrhage/Bleeding 1 1
Device Embedded In Tissue or Plaque 1 1

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