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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
No Apparent Adverse Event 1 1
Break 1 1
Migration or Expulsion of Device 1 1
Device-Device Incompatibility 1 1

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

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