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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mechanical compression device fecal incontinence (non-manually operated)
Definition For treatment of fecal incontinence in patients who have failed conservative therapies
Product CodePMH
Device Class Humanitarian Device Exemption

MDR Year MDR Reports MDR Events
2016 15 15
2017 22 22
2018 6 6
2019 3 3
2020 1 1
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 46 46
Appropriate Term/Code Not Available 3 3
Patient Device Interaction Problem 2 2
Device-Device Incompatibility 1 1
Break 1 1
Migration or Expulsion of Device 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 15 15
Erosion 15 15
Post Operative Wound Infection 8 8
Unspecified Infection 7 7
Constipation 6 6
Wound Dehiscence 5 5
No Code Available 5 5
Incontinence 4 4
Bowel Perforation 2 2
Perforation 2 2
Obstruction/Occlusion 2 2
Hypersensitivity/Allergic reaction 1 1
Cyst(s) 1 1
Hematoma 1 1
Inflammation 1 1
Blood Loss 1 1
Urinary Retention 1 1
Swelling/ Edema 1 1
Hemorrhage/Bleeding 1 1
Pocket Erosion 1 1
Fistula 1 1

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