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 Nausea (1970); Vomiting (2144); Abdominal Cramps (2543)

Event Date 03/25/2021

Event Type  Injury  

Event Description

Nausea, vomiting, abdominal pain, usg showed gall stones [cholelithiasis].Case narrative: this initial spontaneous report was received from the united states of america reported by a physician on 20-jul-2021.A (b)(6) patient of unknown gender (weight: (b)(6)) experienced gallstones while on plenity for weight management.The patient¿s medical history included: asthma.The patient¿s concomitant medications and drug allergies were not reported.On (b)(6) 2021, the patient started therapy with plenity at a dose of three capsules (0.75g) via orally, twice daily for weight management.The lot number and expiry date were not reported.On the same day, after taking plenity the patient had nausea, vomiting and abdominal pain.On (b)(6) 2021, the patient underwent ultrasound examination in the emergency room which showed: gall stones (pt: cholelithiasis) and was advised for surgical removal.The patient advised to have cholecystectomy.The patient had no insurance, hence procedure was kept on hold.The patient reported ongoing symptoms and was advised to decrease the dose of plenity at first and was suggested to visit physician if symptoms were not resolved.On an unspecified date, the patient stopped taking plenity and reported that events were not disappeared after stopping plenity and also recurred after restarting plenity.Based on the patient condition, case was assessed as serious.It was reported that the event was not related to the use of plenity.Action taken: patient discontinued plenity as a result of event cholelithiasis.The outcome of the event cholelithiasis was not resolved at the time of this report.This case was verified by a healthcare professional.Company comment: this spontaneous report refers to a (b)(6) patient who was diagnosed with cholelithiasis 7 days following initiation of therapy with plenity for weight management.Patient reported nausea, vomiting and abdominal pain on the first day of initiating plenity and was diagnosed with cholelithiasis on an ultrasound performed 7 days later in the emergency room.Patient was advised to undergo cholecystectomy.The symptoms were still reported as ongoing and plenity was discontinued.Patient's medical history is significant for asthma.Concomitant medications were not reported.The case is assessed as serious as the events necessitated medical/surgical intervention to prevent further complications of cholelithiasis.The treating physician assessed the events as not related to plenity.Considering the very short latency (1 day) for the development of symptoms associated with cholelithiasis and nature of action of plenity, causality is assessed as unlikely related to plenity.More information regarding medical history, concomitant medications is required for the proper 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: 12335238
• MDR Text Key: 267035791
• Report Number: 3012121187-2021-00361
• 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
• Type of Report: Initial
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 122