TPLC - Total Product Life Cycle

• Device: ingested, transient, space occupying device for weight management and/or weight loss
• Regulation Description: Ingested, transient, space occupying device for weight management and/or weight loss.
• Definition: This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.
• Product Code: QFQ
• Regulation Number: 876.5982
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
EPITOMEE MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
GELESIS, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	3	3
2021	9	9
2022	24	24
2023	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	37	37
Physical Resistance/Sticking	2	2
Improper or Incorrect Procedure or Method	2	2
Output Problem	1	1
Insufficient Information	1	1
Difficult to Remove	1	1
Use of Device Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	16	16
Foreign Body In Patient	8	8
Obstruction/Occlusion	5	5
Hypersensitivity/Allergic reaction	4	4
Dyspnea	4	4
Abdominal Pain	3	3
Nausea	3	3
Vomiting	3	3
Dysphagia/ Odynophagia	3	3
Constipation	3	3
Pancreatitis	2	2
Aspiration/Inhalation	2	2
Rash	2	2
Chest Pain	2	2
Diarrhea	2	2
Hernia	2	2
Hematemesis	2	2
Gastrointestinal Hemorrhage	1	1
Dizziness	1	1
Diabetic Ketoacidosis	1	1
Bowel Perforation	1	1
Unspecified Musculoskeletal problem	1	1
Perforation	1	1
Abdominal Cramps	1	1
Abdominal Distention	1	1
Anaphylactoid	1	1
Pericardial Effusion	1	1
Electrolyte Imbalance	1	1
Dehydration	1	1
Pain	1	1
Ulcer	1	1
Hemorrhage/Bleeding	1	1