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 Diarrhea (1811)

Event Type  Injury  

Event Description

I ended up in the hospital too much bowel movement/major diarrhea for days that put me in the hospital [diarrhoea].Case narrative: this initial spontaneous report was received from the united states of america reported by a consumer via facebook public comment on 11-oct-2022.A female patient of an unknown age reported diarrhea while on plenity for an unknown indication.The patient¿s medical history, current conditions, concomitant medications, drug allergies and usage of other medical devices were not provided.On an unknown date, the patient started therapy with plenity at an unknown dose, route and frequency for an unknown indication.Lot number and expiry date of plenity were not reported.On an unknown date, the patient experienced too much bowel movements described as major diarrhea (pt: diarrhoea) for days and ended up in the hospital.Action taken with plenity, and the outcome of the event diarrhoea was unknown.The case was assessed as serious given the need for hospitalization for the event.This case was not verified by a healthcare professional.Further follow-up not expected for the report.Company comment: this social media case refers to a female patient of unspecified age who reported diarrhea while on plenity for an unknown indication.Patient started therapy with plenity and experienced too much bowel movements described as major diarrhea for days and ended up in the hospital.This case is assessed as serious given the need for hospitalization for the event diarrhea.Based on the plausible temporal relationship and spontaneous nature of the report, causality is assessed as possible for the event diarrhea.

• 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: 15749984
• MDR Text Key: 303235199
• Report Number: 3012121187-2022-01089
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• 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
• 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