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TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
bandage, elastic
Product Code
FQM
Regulation Number
880.5075
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
5
5
2015
8
8
2016
10
10
2017
8
8
2018
13
13
2019
10
10
2020
64
64
2021
73
73
2022
23
23
2023
10
10
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Integrity Problem
47
47
Failure to Unfold or Unwrap
36
36
Adverse Event Without Identified Device or Use Problem
30
30
Mechanical Problem
24
24
Device Difficult to Setup or Prepare
19
19
Nonstandard Device
15
15
Appropriate Term/Code Not Available
11
11
Material Split, Cut or Torn
10
10
Physical Resistance/Sticking
8
8
Patient-Device Incompatibility
8
8
Insufficient Information
7
7
Difficult to Fold, Unfold or Collapse
6
6
Material Puncture/Hole
5
5
Product Quality Problem
5
5
Device Operates Differently Than Expected
5
5
Difficult to Remove
4
4
Loss of or Failure to Bond
3
3
Use of Device Problem
3
3
Defective Component
2
2
Tear, Rip or Hole in Device Packaging
2
2
Device Packaging Compromised
2
2
Device Contamination with Chemical or Other Material
2
2
Human-Device Interface Problem
2
2
Contamination /Decontamination Problem
2
2
Inadequate User Interface
2
2
Melted
2
2
Material Frayed
2
2
Material Too Rigid or Stiff
2
2
Delivered as Unsterile Product
2
2
Material Deformation
2
2
Patient Device Interaction Problem
2
2
Device Handling Problem
1
1
Packaging Problem
1
1
Separation Problem
1
1
Adhesive Too Strong
1
1
Device Emits Odor
1
1
Off-Label Use
1
1
Material Separation
1
1
Sticking
1
1
Leak/Splash
1
1
Loose or Intermittent Connection
1
1
Contamination
1
1
Material Fragmentation
1
1
Compatibility Problem
1
1
Device Contamination With Biological Material
1
1
Inadequate Instructions for Non-Healthcare Professional
1
1
Defective Device
1
1
Biocompatibility
1
1
Incomplete or Missing Packaging
1
1
Device Damaged Prior to Use
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
101
101
No Patient Involvement
36
36
No Consequences Or Impact To Patient
23
23
Itching Sensation
15
15
Pain
11
11
Reaction
10
11
Rash
9
10
Hypersensitivity/Allergic reaction
7
7
No Known Impact Or Consequence To Patient
7
7
Skin Inflammation/ Irritation
6
6
Blister
5
5
Skin Irritation
5
5
Ulcer
4
4
Erythema
4
4
Pulmonary Embolism
4
4
Laceration(s)
4
5
Necrosis
4
4
No Information
3
3
No Code Available
3
3
Tissue Breakdown
2
2
Skin Tears
2
2
Ischemia
2
2
Local Reaction
2
2
Anaphylactic Shock
2
2
Hematoma
2
2
Hemorrhage/Bleeding
2
2
Unspecified Infection
2
2
Skin Erosion
2
3
Infection, Direct
2
2
Complaint, Ill-Defined
2
2
Injury
2
2
Numbness
1
1
Post Traumatic Wound Infection
1
1
Discomfort
1
1
Swelling
1
1
Ulceration
1
1
Burning Sensation
1
1
Tingling
1
1
Peeling
1
1
Discharge
1
1
Irritation
1
1
Burn(s)
1
1
Cellulitis
1
1
Scarring
1
1
Skin Discoloration
1
1
Wound Dehiscence
1
1
Caustic/Chemical Burns
1
1
Partial thickness (Second Degree) Burn
1
1
Not Applicable
1
1
Skin Burning Sensation
1
1
Contact Dermatitis
1
1
Insufficient Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
ASO LLC
II
Aug-12-2022
2
Afassco Inc
II
Aug-08-2012
3
Amd-Ritmed, Inc.
II
Jul-15-2016
4
Andover Healthcare Inc.
II
Oct-23-2019
5
BSN Medical Inc
II
Jun-03-2022
6
Cardinal Health
II
Jan-16-2009
7
Johnson & Johnson Consumer, Inc.
II
Mar-27-2018
8
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
9
Medline Industries Inc
II
Dec-29-2017
10
Medline Industries Inc
II
Jan-23-2017
11
Medline Industries Inc
II
May-21-2014
12
North American Rescue LLC.
II
Sep-25-2020
13
Tactical Medical Solutions, Inc.
II
Jul-25-2018
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