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TPLC
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show TPLC since
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2024
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Device
tape and bandage, adhesive
Product Code
KGX
Regulation Number
880.5240
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
484
484
2020
1290
1290
2021
560
560
2022
253
253
2023
193
193
2024
142
146
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1138
1138
Loss of or Failure to Bond
734
734
Material Integrity Problem
153
153
Delivered as Unsterile Product
116
116
Insufficient Information
92
92
Patient-Device Incompatibility
61
61
Device Slipped
54
54
Detachment of Device or Device Component
50
50
Contamination /Decontamination Problem
49
49
Appropriate Term/Code Not Available
43
43
Biocompatibility
33
33
Product Quality Problem
32
32
Migration
30
30
Nonstandard Device
29
29
Defective Device
26
26
Difficult to Remove
25
25
Peeled/Delaminated
25
25
Device Dislodged or Dislocated
24
24
Unintended Movement
20
20
Mechanical Problem
19
19
Patient Device Interaction Problem
18
18
Packaging Problem
18
18
Defective Component
17
17
Physical Resistance/Sticking
17
17
Material Separation
16
16
Failure to Obtain Sample
14
14
Material Disintegration
14
14
Unsealed Device Packaging
13
13
Device Contamination with Chemical or Other Material
12
12
Use of Device Problem
12
12
Contamination
11
11
Material Deformation
11
11
Leak/Splash
10
10
Device Contaminated During Manufacture or Shipping
9
9
Manufacturing, Packaging or Shipping Problem
8
8
Separation Problem
7
7
Device Difficult to Setup or Prepare
6
6
Improper or Incorrect Procedure or Method
5
5
Difficult to Open or Close
5
9
Difficult to Open or Remove Packaging Material
5
5
Failure to Unfold or Unwrap
4
4
Tear, Rip or Hole in Device Packaging
4
4
Problem with Sterilization
4
4
Component Missing
3
3
Missing Information
3
3
Device Contamination with Body Fluid
3
3
Device Markings/Labelling Problem
3
3
Microbial Contamination of Device
3
3
Break
3
3
Therapeutic or Diagnostic Output Failure
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
613
617
No Known Impact Or Consequence To Patient
602
602
Injury
279
279
No Consequences Or Impact To Patient
230
230
Unspecified Infection
210
210
Rash
186
186
Skin Inflammation/ Irritation
137
137
Itching Sensation
125
125
Erythema
112
112
No Patient Involvement
108
108
Hypersensitivity/Allergic reaction
106
106
Skin Irritation
104
104
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
100
100
Skin Tears
99
99
Pain
89
89
Blister
83
83
No Code Available
79
79
Peeling
67
67
Burning Sensation
50
50
Abrasion
50
50
Skin Infection
39
39
Local Reaction
38
38
Unspecified Tissue Injury
38
38
Hemorrhage/Bleeding
35
35
Swelling
35
35
Insufficient Information
34
34
Bacterial Infection
34
34
Reaction
32
32
Skin Burning Sensation
26
26
Contact Dermatitis
25
25
Skin Discoloration
25
25
Purulent Discharge
23
23
Fluid Discharge
22
22
Burn(s)
21
21
Impaired Healing
21
21
Swelling/ Edema
20
20
Post Operative Wound Infection
20
20
Wheal(s)
18
18
Scar Tissue
18
18
Wound Dehiscence
18
18
Caustic/Chemical Burns
16
16
Failure of Implant
15
15
Tissue Breakdown
13
13
Localized Skin Lesion
12
12
Urticaria
10
10
Dyspnea
8
8
Skin Erosion
7
7
Ulcer
7
7
Inflammation
7
7
Necrosis
7
7
Recalls
Manufacturer
Recall Class
Date Posted
1
3M Company - Health Care Business
II
Apr-24-2024
2
3M Company - Health Care Business
II
Apr-03-2024
3
3M Company - Health Care Business
II
Dec-20-2019
4
ASO LLC
II
May-02-2023
5
Cardinal Health 200, LLC
II
May-16-2024
6
Family Dollar Stores, Llc.
II
Aug-17-2022
7
MEDLINE INDUSTRIES, LP - Northfield
II
Mar-29-2024
8
Mckesson Medical-Surgical Inc. Corporate Office
III
Sep-26-2022
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