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 Dyspnea (1816)

Event Type  Injury  

Event Description

Chest tightness that evolved to shortness of breath [chest discomfort].Chest tightness that evolved to shortness of breath [dyspnoea].Case narrative: this initial spontaneous report was received from the united states of america reported by an health care professional on (b)(6) 2023.A 43-year-old patient of unknown gender experienced chest tightness and shortness of breath while on plenity for weight management.The patient¿s medical history included a cholecystectomy in 2018.Concurrent conditions included a sugar addiction with a bes (binge eating scale) score of 10, and patient disclosed having gerd (gastroesophageal reflux disease) which was controlled and often needed to clear the throat for no apparent reason associated with allergies.The patient had known allergies to latex, sulfa, penicillin, and kiwi active ingredients, which required allergy testing and care from an allergist.Concomitant medication included vitamin a.On (b)(6) 2023, the patient started therapy with plenity at a dose of 3 capsules, oral, twice daily for weight management.Lot number and expiry date of plenity were not provided.On an unknown date, approximately two weeks ago, the patient experienced chest tightness (pt: chest discomfort) that evolved to shortness of breath (pt: dyspnoea).The patient called 911 and was treated with an epipen by paramedics, and transferred to the er (emergency room) via ambulance.The patient was observed overnight.Additional treatment received in the ed was not provided.The patient recovered approximately 12 hours after the onset of symptoms.The patient was advised not to restart plenity due to the severity of symptoms.The patient was provided with plenity¿s ingredient list to review with an allergist.The reporter thought that the events were possibly related to plenity as the patient had a kiwi allergy and might have experienced a cross-allergic reaction with citric acid found in plenity.Action taken: patient discontinued plenity due to events of chest discomfort and dyspnea.Outcome of the events of chest discomfort and dyspnea was reported as resolved.This case is assessed as serious given the need for intervention and overnight observation in the er required for the events chest discomfort and dyspnea this case was verified by a healthcare professional.Company comment: this spontaneous report refers to a 43-year-old patient of unknown gender who experienced chest discomfort and dyspnea while on plenity for weight management.The patient¿s medical history included a cholecystectomy and concurrent conditions included sugar addiction, and gerd.The patient has known allergies to latex, sulfa, penicillin, and kiwi active ingredients, which require allergy testing and care from an allergist.The patient experienced chest discomfort and dyspnea, called 911 and was treated with an epipen by paramedics and transferred to the er.The patient was observed overnight and recovered approximately 12 hours after the onset of symptoms.This case is assessed as serious given the need for intervention and overnight observation in the er required for the events chest discomfort and dyspnea.Based on the reasonable temporal relationship, spontaneous nature of the report, and known history of allergies causality is assessed as possible for both events.More information regarding underlying etiology, and investigations is required for a more 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: 16512717
• MDR Text Key: 310984575
• Report Number: 3012121187-2023-00004
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2023
• 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
• Treatment: VITAMIN A (RETINOL).
• Patient Outcome(s): Required Intervention