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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cover, barrier, protective
Product CodeMMP
Regulation Number 878.4370
Device Class 2


Premarket Reviews
ManufacturerDecision
MTP MEDICAL TECHNICAL PROMOTION GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1 1
2015 3 3
2016 1 1
2018 1 1
2019 4 4
2021 1 1
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 2 2
Contamination 2 2
Delivered as Unsterile Product 2 2
Material Puncture/Hole 2 2
Component Missing 1 1
Structural Problem 1 1
Expiration Date Error 1 1
Split 1 1
Break 1 1
Torn Material 1 1
Packaging Problem 1 1
Leak/Splash 1 1
Unsealed Device Packaging 1 1
False Negative Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4 4
No Clinical Signs, Symptoms or Conditions 4 4
No Information 3 3
No Consequences Or Impact To Patient 3 3
Foreign Body In Patient 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LLC II Mar-04-2017
2 GE Medical Systems, LLC II Sep-01-2009
3 GE Medical Systems, LLC II Aug-14-2009
4 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
5 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
6 Metrex Research, LLC. II Nov-27-2012
7 NOVADAQ TECHNOLOGIES INC. II Sep-28-2017
8 Penner Mfg Inc II Mar-20-2015
9 Stryker Corporation II May-07-2020
10 Sybron Dental Specialties II Mar-18-2015
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