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 Foreign Body In Patient (2687)

Event Date 01/02/2023

Event Type  Injury  

Event Description

One of the pills got stuck in my esophagus and i had to have it surgically removed at the hospital [foreign body in throat] she took plenity about four days per week [wrong technique in device usage process].Case narrative: this initial spontaneous report was received from the united states of america reported by a physician on (b)(6) 2023.A 49-year-old adult female patient (weight 158 lbs) reported medication stuck in throat and wrong technique in device usage process while on plenity for weight management.The patient had no medical history, current conditions, concomitant medications, drug allergies and was not using any medical devices.On (b)(6) 2022, the patient started therapy with plenity, at a dose of 3 capsules by mouth twice a day for weight management.Lot number and expiry date of plenity were not reported.On (b)(6) 2023, the patient completed a 14-day questionnaire in regard to plenity and her responses were positive and reported that she took plenity about four days per week (pt: wrong technique in device usage process).On (b)(6) 2023, the patient reported that one of the pills got stuck in her esophagus (pt: foreign body in throat) and she was admitted to the hospital.On the same day, the pill was removed surgically and her plenity treatment plan was cancelled immediately.Action taken: patient discontinued plenity due to the event foreign body in throat.The outcome of the event foreign body in throat was resolved.The case is assessed as serious based on the intervention provided (plenity pill was removed surgically) and hospitalization this case was verified by a healthcare professional.A medical device complaint had been registered with this report.Company comment: this spontaneous report refers to a 49-year-old female patient who reported medication stuck in throat and wrong technique in device usage process (took plenity about four days per week) while on plenity for weight management.The case is assessed as serious based on the intervention provided (plenity pill was removed surgically) and hospitalization.Plenity was discontinued and the event medication stuck in throat was resolved on surgical removal of the plenity pill in the hospital.Considering the plausible temporal association (event occurred 21 days after starting plenity) and spontaneous nature of the report, the causality for the event medication stuck in throat is assessed as possible with plenity.The causality for the event wrong technique in device usage process is assessed as not applicable as it is regarded as a special situation.

• 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: 16370904
• MDR Text Key: 309476132
• Report Number: 3012121187-2023-00002
• 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: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 72 KG