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

Device Problem Physical Resistance/Sticking (4012)

Patient Problems Aspiration/Inhalation (1725); Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 03/01/2022

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 286869416
• Report Number: MW5107922
• 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: Physician
• 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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White