MAUDE Adverse Event Report: GELESIS SRL PLENITY; DELIVERY SYSTEM

Model Number MC0684

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

Patient Problem Foreign Body In Patient (2687)

Event Date 08/20/2022

Event Type  Injury  

Event Description

Plenity capsule getting stuck in his throat [foreign body in throat].Case narrative: this initial spontaneous report was received from the united states of america reported by a consumer on (b)(6) 2022.A 68-year-old male patient (weight: 231 lbs) reported medication stuck in throat while on plenity for weight management.The patient¿s baseline weight was 240 lbs, concurrent conditions included: protein in the kidneys, indigestion and was allergic to latex.The patient did not used any other medical devices.The patient¿s concomitant medications included: prilosec (omeprazole), losartan (losartan potassium) and multivitamin (details unspecified).On (b)(6) 2022, the patient purchased plenity (lot number: a21354b1, expiry: 20-jun-2023, and udi number: (b)(4) and started therapy obtained from health care professional (hcp) with 3 capsules, twice daily (taking at noon, eating lunch around 1:30 pm, and at 5pm and eating dinner around 7 pm) with 16 oz of water) for weight management.On (b)(6) 2022, the patient took 3 plenity capsules, one after the other with water, however one capsule got stuck in his throat (pt: foreign body in throat).He went to the emergency room (er) to get it removed and it was a traumatic experience.The patient saw his x-ray in the emergency room which showed a partial capsule and particles that reminded him of styrofoam pieces.On the same day, the patient recovered from the event and felt the event was related to the use of plenity.Action taken: patient discontinued plenity due to event foreign body in throat.Outcome of the event foreign body in throat was resolved.The case is assessed as serious based on the event requiring retrieval of the capsule (intervention) in emergency room.This case was not verified by a healthcare professional.Further follow-up was not expected for this report.Company comment: this spontaneous report refers to a 68-year-old male patient who reported medication stuck in throat while on plenity for weight management.Medical history is significant for protein in the kidneys, indigestion, and latex allergies; and concomitant medications included prilosec, losartan, and multivitamin.After using plenity for about 3 weeks, the patient reported that one of the plenity capsules got stuck in his throat, so he went to the er where it was retrieved and the event resolved.He also reported seeing a partial capsule on his x-ray.Patient discontinued plenity due to the event.The case is assessed as serious based on the event requiring retrieval of the capsule (intervention) in emergency room.Considering the plausible temporal association (event occurred approximately 3 weeks after start of plenity) and spontaneous nature of the report, the causality for the event is assessed as possible with plenity.

• 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: 15389343
• MDR Text Key: 299562503
• Report Number: 3012121187-2022-01006
• Device Sequence Number: 1
• Product Code: QFQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/09/2022

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 Expiration Date: 06/20/2023
• Device Model Number: MC0684
• Device Lot Number: A21354B1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2022
• 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: LOSARTAN (LOSARTAN POTASSIUM),; PRILOSEC (OMEPRAZOLE),
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 105 KG