MAUDE Adverse Event Report: GELESIS, S.R.L./ GELESIS INC. PLENITY GELESIS 100; INGESTED, TRANSIENT, SPACE OCCUPYING DEVICE FOR WEIGHT MANAGEMENT AND/OR WEIGHT

Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Hemorrhage/Bleeding (1888); Pain (1994)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Plenity (gelesis100) became lodged in patient's throat upon swallowing.She presented to the emergency department, where an endoscopy was conducted to extract the foreign body.During this endoscopy, the patient experienced an aspiration event complicated by the absorption of fluid by and expansion of the plenity capsules.The patient also experienced bleeding and pain in her esophagus due to plenity impaction.The foreign body was successfully extracted during the endoscopy procedure, and the patient was monitored overnight before being released one day following ed admission.Fda safety report id#:(b)(4).

• Brand Name: PLENITY GELESIS 100
• Common Device Name: INGESTED, TRANSIENT, SPACE OCCUPYING DEVICE FOR WEIGHT MANAGEMENT AND/OR WEIGHT
• Manufacturer (Section D): GELESIS, S.R.L./ GELESIS INC.; calimera, lecce 73021 ; IT 73021
• MDR Report Key: 13691920
• Report Number: MW5107922
• Device Sequence Number: 16381388
• Product Code: QFQ
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2022

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
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White