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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dressing, wound, drug
Product CodeFRO
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT - WITH DRUG 1
  3
  SUBSTANTIALLY EQUIVALENT 7
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ABIGO MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 3
ACRYMED, INC.
  SUBSTANTIALLY EQUIVALENT 9
ADVANCE MEDICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 8
ALBA HEALTH
  SUBSTANTIALLY EQUIVALENT 2
AMERICAN BIOTECH LABS
  SUBSTANTIALLY EQUIVALENT 2
ANACAPA TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
ANDOVER
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASO LLC
  SUBSTANTIALLY EQUIVALENT 1
AT SQUARED, LLC
  SUBSTANTIALLY EQUIVALENT 1
AUBREY GROUP
  SUBSTANTIALLY EQUIVALENT 1
AXIOM
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
BAXTER HEALTHCARE CORP.
  1
  SUBSTANTIALLY EQUIVALENT 1
BEIERSDORF
  2
  SUBSTANTIALLY EQUIVALENT 5
BIOARTIFICIAL GEL TECHNOLOGIES (BAGTECH) INC
  SUBSTANTIALLY EQUIVALENT 2
BIOLIFE, LLC
  SUBSTANTIALLY EQUIVALENT 3
BIOSEAL
  SUBSTANTIALLY EQUIVALENT 1
BLAIREX LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
  2
COLLAMATRIX CO., INC.
  SUBSTANTIALLY EQUIVALENT 2
COLLEGIUM PHARMACEUTICAL INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
COLOPLAST MANUFACTURING US LLC
  2
  SUBSTANTIALLY EQUIVALENT 3
CONVATEC LIMITED
  SUBSTANTIALLY EQUIVALENT 2
CROSSLINK-D, INC
  SUBSTANTIALLY EQUIVALENT 1
CRYOLIFE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DERMA SCIENCES CANADA, INC.
  SUBSTANTIALLY EQUIVALENT 10
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
DOW
  SUBSTANTIALLY EQUIVALENT 1
DURDEN ENTERPRISES
  SUBSTANTIALLY EQUIVALENT 1
DYNAREX
  1
  SUBSTANTIALLY EQUIVALENT 2
EMERGENCY MEDICAL DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ENZYSURGE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
EURO-MED
  SUBSTANTIALLY EQUIVALENT 2
FERNDALE LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
FERRIS MFG. CORP.
  SUBSTANTIALLY EQUIVALENT 1
  4
FIDIA FARMACEUTICI SPA
  SUBSTANTIALLY EQUIVALENT 2
GORBEC PHARMACEUTICAL SERVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GRAHAM-FIELD HEALTH PRODUCTS, INC.
  1
HEALAGENICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEMCON MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 13
Hemostasis, LLC
  SUBSTANTIALLY EQUIVALENT 5
HOLLISTER, INC.
  1
  SUBSTANTIALLY EQUIVALENT 2
IGI LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA
  SUBSTANTIALLY EQUIVALENT 4
JOHNSON & JOHNSON
  4
  SUBSTANTIALLY EQUIVALENT 10
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
  2
KYTOGENICS, INC
  SUBSTANTIALLY EQUIVALENT 1
LABORATOIRES URGO
  SUBSTANTIALLY EQUIVALENT 6
LIFESCIENCE PLUS, INC.
  SUBSTANTIALLY EQUIVALENT 2
LINKDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
MARINE POLYMER TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MCMERLIN DENTAL PRODUCTS LP
  SUBSTANTIALLY EQUIVALENT 1
MEDAFOR, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL MOLECULAR THERAPUETICS LLC
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 5
MEDTRADE PRODUCTS LTD.
  SUBSTANTIALLY EQUIVALENT 15
MILLIKEN & CO.
  SUBSTANTIALLY EQUIVALENT 3
MODERN MEDICAL EQUIPMENT MFG., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MOLNLYCKE HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 4
MUELLER
  SUBSTANTIALLY EQUIVALENT 1
NOBLE
  SUBSTANTIALLY EQUIVALENT 3
NOVABAY PHARMACEUTICALS
  SUBSTANTIALLY EQUIVALENT 2
NUCRYST PHARMACEUTICALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NURSE ASSIST, INC.
  SUBSTANTIALLY EQUIVALENT 1
OCULUS INNOVATIVE SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 7
ORGANOGENESIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PATRICK D. MCGRATH PH.D
  SUBSTANTIALLY EQUIVALENT 1
PFIZER
  SUBSTANTIALLY EQUIVALENT 1
POLYMEDICS INNOVATIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
PRIMARY CARE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PURICORE, INC.
  SUBSTANTIALLY EQUIVALENT 2
QUINNOVA PHARMACEUTICALS
  SUBSTANTIALLY EQUIVALENT 3
RADI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SCION CARDIO-VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 3
SILVERLEAF MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SINCLAIR PHARMACEUTICALS, LTD.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  5
  SUBSTANTIALLY EQUIVALENT 8
SOUTHWEST TECHNOLOGIES, INC.
  1
  SUBSTANTIALLY EQUIVALENT 2
SPECIALTY FIBRES AND MATERIALS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPENCO
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL SPECIALTIES CORP.
  SUBSTANTIALLY EQUIVALENT 1
SWISS
  SUBSTANTIALLY EQUIVALENT 3
TEI BIOSCIENCES INC.
  SUBSTANTIALLY EQUIVALENT 1
TISSUE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
TraumaCure Inc.
  SUBSTANTIALLY EQUIVALENT 2
TRIOSYN CORP.
  SUBSTANTIALLY EQUIVALENT 1
TRISTATE
  SUBSTANTIALLY EQUIVALENT 1
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 4
TZ MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 17
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 2
Z-MEDICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 8

Device Problems
No Known Device Problem 230
Foreign material present in device 71
Delivered as unsterile product 32
Device operates differently than expected 30
Unsealed device packaging 30
Use of Device Issue 24
Patient-device incompatibility 23
Device packaging compromised 22
Failure to Adhere or Bond 20
Packaging issue 19
No Information 18
Difficult to remove 18
Unknown (for use when the device problem is not known) 16
Product quality issue 15
Improper or incorrect procedure or method 13
No code available 13
Increased sensitivity 12
Sticking 12
Tear, rip or hole in device packaging 9
Human-Device Interface Issue 9
Material frayed 8
Defective item 8
Other (for use when an appropriate device code cannot be identified) 8
Device handling issue 7
Material separation 7
Material fragmentation 7
Manufacturing or shipping issue associated with device 5
Torn material 4
Shelf life exceeded 4
Hole in material 4
Protective measure issue 4
Material integrity issue 4
Material discolored 3
Material disintegration 3
Device expiration issue 3
Reaction 3
Device markings issue 2
User used incorrect product for intended use 2
Device emits odor 2
Item contaminated during manufacturing or shipping 2
Device, removal of (non-implant) 2
Buckled material 2
Increase in suction 2
Structural problem 1
Suction issue 1
Not Applicable 1
Component missing 1
Delamination 1
Particulates 1
Increase in pressure 1
Expiration date error 1
Failure to sterilize 1
Device Cleaning Issue 1
Infusion or flow issue 1
Device, or device fragments remain in patient 1
Contamination during use 1
Leak 1
Failure to disinfect 1
Out-of-box failure 1
Flaked 1
Moisture or humidity problem 1
Difficult to open or remove packaging material 1
Failure to align 1
No fail-safe mechanism 1
Inadequate user interface 1
Total Device Problems 754

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 1 0 0 0
Class II 3 0 1 0 1 1 1 1 3 5 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Acrymed Incorporated II Nov-29-2011
2 Advanced Medical Solutions Ltd. II Sep-02-2016
3 Bard Access Systems II Dec-01-2014
4 Belcher Pharmaceuticals Inc. II Feb-07-2007
5 CareFusion 303, Inc. II Mar-24-2016
6 Coreva Health Science LLC II May-30-2015
7 Integra Biotechnical LLC II Apr-04-2007
8 Integra LifeSciences Corp. II Apr-07-2009
9 Kensey Nash Corp II May-31-2007
10 Medical Action Industries Inc II Mar-02-2016
11 Oculus Innovative Sciences Inc II Feb-26-2013
12 Oculus Innovative Sciences Inc II Jan-11-2012
13 Oculus Innovative Sciences, Inc. II Dec-14-2016
14 TZ Medical Inc. II Nov-19-2015
15 TZ Medical Inc. II Nov-18-2015
16 TZ Medical, Inc. II Oct-21-2016
17 Wellspring Pharmaceutical Corporation I Jul-29-2014

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