TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Burst Container or Vessel	475	476
Material Puncture/Hole	252	252
Material Rupture	223	223
Fracture	146	146
Fluid/Blood Leak	114	114
Failure to Deflate	113	113
Leak/Splash	111	111
Adverse Event Without Identified Device or Use Problem	109	109
Inflation Problem	72	72
Difficult to Remove	65	65
Use of Device Problem	55	55
Deflation Problem	54	54
Detachment of Device or Device Component	36	36
Break	31	31
Material Twisted/Bent	22	22
Off-Label Use	22	22
Material Integrity Problem	15	15
Deformation Due to Compressive Stress	12	12
Material Fragmentation	10	10
Improper or Incorrect Procedure or Method	9	9
Material Deformation	7	7
Material Split, Cut or Torn	7	7
Difficult to Advance	6	6
Loss of or Failure to Bond	5	5
Mechanical Problem	4	4
Gas/Air Leak	3	3
Incomplete or Missing Packaging	3	3
Device Damaged Prior to Receipt by User	3	3
Entrapment of Device	3	3
Device-Device Incompatibility	3	3
Use of Incorrect Control/Treatment Settings	3	3
Contamination	2	2
Device Contamination with Chemical or Other Material	2	2
Connection Problem	2	2
Device Damaged by Another Device	2	2
Tear, Rip or Hole in Device Packaging	2	2
Accessory Incompatible	2	2
Physical Resistance/Sticking	2	2
Activation, Positioning or Separation Problem	1	1
Crack	1	1
Infusion or Flow Problem	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Obstruction of Flow	1	1
Difficult to Insert	1	1
Failure to Advance	1	1
Packaging Problem	1	1
Defective Device	1	1
Material Perforation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1571	1573
Insufficient Information	33	34
No Consequences Or Impact To Patient	19	19
Foreign Body In Patient	16	16
Hemorrhage/Blood Loss/Bleeding	9	9
Perforation of Esophagus	9	9
Laceration(s) of Esophagus	7	7
Gastrointestinal Hemorrhage	6	6
Unspecified Tissue Injury	5	5
Pancreatitis	2	2
Laceration(s)	2	2
Perforation	2	2
Aspiration/Inhalation	2	2
Low Oxygen Saturation	2	2
Cough	2	2
Pain	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Abdominal Pain	1	1
Fever	1	1
Anxiety	1	1
Skin Inflammation/ Irritation	1	1
Inflammation	1	1
Device Embedded In Tissue or Plaque	1	1
Stenosis	1	1
Obstruction/Occlusion	1	1
Embolism/Embolus	1	1
Abscess	1	1
Vomiting	1	1
Unspecified Gastrointestinal Problem	1	1
Needle Stick/Puncture	1	1
Fistula	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Diversatek Healthcare	II	Apr-23-2026