MAUDE Adverse Event Report: GELESIS SRL PLENITY; DELIVERY SYSTEM

Model Number MC0420

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dehydration (1807); Diarrhea (1811); Electrolyte Imbalance (2196)

Event Type  Injury  

Event Description

Constant diarrhea [diarrhoea].Dehydration [dehydration].Electrolyte imbalance [electrolyte imbalance].Case narrative: this initial spontaneous report was received from the united states of america by a ro physician on (b)(6) 2022.A 66-year-old female patient (weight: 167 lbs) reported diarrhea, dehydration and electrolyte imbalance while on plenity for an unknown indication.The patient¿s current condition included: osteoarthritis, hypercholesterolemia; no other medical history, drug allergies, concomitant medication and usage of other medical devices were reported.On (b)(6) 2022, the patient started therapy with plenity at a dose of 3 capsules, orally, about 20 min prior to meals, lunch and dinner for an unknown indication.Lot number and expiry date of plenity were not reported.On an unknown date, after taking plenity, the patient experienced constant diarrhea (pt: diarrhoea), resulting in dehydration (pt: dehydration) and electrolyte imbalances (pt: electrolyte imbalances), which led to hospitalization.The patient had requested a refund after being discharged from the hospital.On an unknown date, the patient stopped taking plenity and the reporter suspected that plenity potentially contributed to the recent symptoms of diarrhea.It was reported that events disappeared after stopping plenity.This case is assessed as serious given the need for hospitalization for the events diarrhoea, dehydration and electrolyte imbalance.Action taken: patient discontinued plenity due to events diarrhoea, dehydration and electrolyte imbalance.Outcome of the events diarrhoea, dehydration and electrolyte imbalance were resolved.This case was verified by a healthcare professional.Company comment: this spontaneous report refers to a 66-year-old female patient who reported diarrhea, dehydration and electrolyte imbalance while on plenity for an unknown indication.The patient experienced diarrhea, resulting in dehydration and electrolyte imbalance which led to hospitalization.Plenity was discontinued because of the events and the events resolved.This case is assessed as serious given the need for hospitalization for the events diarrhoea, dehydration and electrolyte imbalance.Based on the reasonable temporal relationship, positive dechallenge and spontaneous nature of the report, causality is assessed as possible for the events.

• Brand Name: PLENITY
• Type of Device: DELIVERY SYSTEM
• Manufacturer (Section D): GELESIS SRL; via verdi, 188; calimera (le) 73021 ; IT 73021
• Manufacturer (Section G): GELESIS, INC.; 501 boylston street, suite 610; 2; boston MA 02116
• Manufacturer Contact: via verdi, 188; calimera (le) 73021
• MDR Report Key: 15578442
• MDR Text Key: 301560950
• Report Number: 3012121187-2022-01027
• Device Sequence Number: 1
• Product Code: QFQ
• Combination Product (y/n): N
• PMA/PMN Number: DEN180060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MC0420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 76 KG