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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device clip, tubal occlusion
Definition Call for PMAs 12/30/87 (52 FR 36883 10/1/87))
Product CodeHGB
Regulation Number 884.5380
Device Class 3

MDR Year MDR Reports MDR Events
2014 1 1
2015 4 4
2016 1 1
2020 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 7 7
Device Operates Differently Than Expected 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Migration 2 2
Nonstandard Device 1 1
Improper or Incorrect Procedure or Method 1 1
Unstable 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 10 10
Wound Dehiscence 2 2
No Known Impact Or Consequence To Patient 2 2
Fever 2 2
Pain 2 2
Abdominal Pain 1 1
Unspecified Infection 1 1
Fatigue 1 1
Memory Loss/Impairment 1 1
Rash 1 1
Laceration(s) 1 1
Hemorrhage/Bleeding 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. d.b.a. Integra Pain Management II Sep-19-2013
2 Richard Wolf Medical Instruments Corp. II Nov-17-2009
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