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 05/02/2022

Event Type  Injury  

Event Description

Pill got stuck in patient's 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 (b)(6) female patient (weight (b)(6) lbs) reported medication stuck in throat while on plenity for unknown indication.The patient had no medical history, concurrent conditions, concomitant medications, drug allergies and usage of other medical devices.On (b)(6) 2022, the patient started oral therapy with plenity, three capsules twice daily for unknown indication.The lot number and expiry date of plenity were not reported.On (b)(6) 2022, the patient reported that the pill got stuck in throat (pt: foreign body in throat) and went to er and had esophagogastroduodenoscopy (egd) to remove lodged capsule in throat.On (b)(6) 2022, the patient got hospitalized, discharged, and the event foreign body in throat recovered.It was reported that there was a possible suspicion that plenity might have contributed to the event and was withdrawn.This case was assessed as serious based on hospitalization and surgical intervention in the form of endoscopic removal of plenity capsules for resolution of the symptoms.Action taken: patient discontinued plenity as a result of event.Outcome: the event foreign body in throat was resolved.This case was verified by a healthcare professional.Company comment: this spontaneous report refers to a (b)(6) female patient(weight (b)(6)) who reported foreign body in throat after being on plenity for 8 days for unknown indication.The patient went to the er and underwent esophagogastroduodenoscopy for removal of the capsule.Patient was discharged on the same day.The case is assessed as serious based on hospitalization and surgical intervention in the form of endoscopic removal of plenity capsules for resolution of the symptoms.Based on the reasonable temporal relationship, causality is assessed as possible.More information regarding medical history and concomitant medication is required for proper assessment of the case.

Event Description

Pill got stuck in patient's 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 49-year-old female patient (weight 225lbs) reported medication stuck in throat while on plenity for obesity.The patient had no medical history, concurrent conditions, drug allergies and usage of other medical devices.Concomitant medications included: colace, claritin, and premarin.On (b)(6) 2022, the patient started oral therapy with plenity, three capsules twice daily for obesity as directed.The lot number and expiry date of plenity were not reported.On (b)(6) 2022, the patient reported that the pill got stuck in throat (pt: foreign body in throat).The patient never had difficulty in swallowing pills or any food lodged in her throat before.On (b)(6) 2022, the patient went to er and had esophagogastroduodenoscopy (egd) to remove lodged capsule in throat.The patient was not admitted to hospital,and presented to er and procedure was done the event foreign body in throat recovered.It was reported that there was a possible suspicion that plenity might have contributed to the event and was withdrawn.The case is assessed as serious as patient required surgical intervention in the form of endoscopic removal of plenity capsules for resolution of the symptoms in the er.Action taken: patient discontinued plenity as a result of event.The outcome of the event foreign body in throat was resolved.This case was verified by a healthcare professional.Follow up information received on 27-may-2022 included: indication of plenity, concomitant medications, egd performed date and narrative amended.Company comment: this spontaneous report refers to a 49-year-old female patient (weight 225lbs) who reported foreign body in throat after being on plenity for 8 days for unknown indication.The patient reported she has never had any difficulty swallowing pills or any food in past.The patient went to the er and underwent esophagogastroduodenoscopy for removal of the capsule.Patient was discharged on the same day.The case is assessed as serious as patient required surgical intervention in the form of endoscopic removal of plenity capsules for resolution of the symptoms in the er.Based on the reasonable temporal relationship, causality is assessed as possible.

• 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: 14352202
• MDR Text Key: 291350192
• Report Number: 3012121187-2022-00051
• 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,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• 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
• 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: Initial
• Patient Sequence Number: 1
• Treatment: CLARITIN (LORATADINE),; COLACE (DOCUSATE SODIUM),; PREMARIN (ESTROGENS CONJUGATED),
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Sex: Female
• Patient Weight: 102 KG