MAUDE Adverse Event Report: GELESIS SRL PLENITY; DELIVERY SYSTEM

Model Number MC0420

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Colitis [colitis].Case narrative: this initial spontaneous report was received from the united states of america by a ro physician on (b)(6) 2022.A 68-year-old, female patient (weight: 235 lbs) experienced colitis while on plenity for weight management.The patient¿s current condition included hypothyroidism.No other medical history, drug allergies and usage of other medical devices were reported.The patient's concomitant medication included levothyroxine.On (b)(6) 2022, the patient started therapy with plenity at a dose of 0.75 gm, orally, twice daily for weight management.Lot number and expiry date of plenity were not reported.On an unknown date, the patient was hospitalized with colitis (pt: colitis) and discontinued plenity.On an unknown date, the event colitis was resolved.Action taken: patient discontinued plenity due to event colitis.Outcome of the event colitis was resolved.The case is assessed as serious due to the need for hospitalization.This case was verified by a healthcare professional.Company comment: this spontaneous report refers to a 68-year-old, female patient who experienced colitis while on plenity for weight management.The patient¿s current condition included hypothyroidism and concomitant medication included levothyroxine.The event colitis resulted in hospitalization following which plenity was discontinued and the symptoms resolved.The case is assessed as serious due to the need for hospitalization.Considering the reasonable temporal relationship, positive dechallenge, and spontaneous nature of the report, the causality is assessed as possible for the event colitis.More information regarding relevant medical history, details about the events leading to hospitalization, investigations done, and treatment provided is needed for a meaningful assessment of the case.

• 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: 15216317
• MDR Text Key: 297769942
• Report Number: 3012121187-2022-00843
• 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: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• 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: A
• Patient Sequence Number: 1
• Treatment: LEVOTHYROXINE (LEVOTHYROXINE),
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 107 KG