MAUDE Adverse Event Report: GELESIS, INC. PLENITY; INGESTED, TRANSIENT, SPACE OCCUPYING DEVICE FOR WEIGHT MANAGEMENT AND/OR WEIGHT

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/01/2022

Event Type  Injury  

Event Description

Plenity prescription weight loss supplement.It is supposed to expand in your stomach to make you feel full.The pill got stuck in my esophagus and expanded there.They did an endoscopy but the gel was so coagulated they had trouble removing it.They did eventually get it but there were complications and i was hospitalized overnight.This could have been life threatening, had i not gotten to the er right away or if it had lodged higher up.

• Brand Name: PLENITY
• Type of Device: INGESTED, TRANSIENT, SPACE OCCUPYING DEVICE FOR WEIGHT MANAGEMENT AND/OR WEIGHT
• Manufacturer (Section D): GELESIS, INC.
• MDR Report Key: 13691859
• MDR Text Key: 286851204
• Report Number: MW5107918
• Device Sequence Number: 1
• Product Code: QFQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: BREO INHALER; BUPOPRION; DAILY VITAMIN ; DUPIXENT; VENLAFAXINE
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White