UNKNOWN
Received Jun 25, 2025 · Event occurred Jun 13, 2025
Report MW5171992 · MDR key 22340484
Device
Generic name
Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss
Manufacturer
UnknownModel number
GASTRIC SLEEVEProduct problems
- Data Problem
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
WHEN ASSISTING A USER WITH AN "INVALID DATA" ERROR, I SAW THE FOLLOWING MESSAGE: "THIS PATIENT HAS TRIED OTHER MEDICATIONS SUCH AS ADDERALL, WELLBUTRIN (ADVERSE REACTION, LISTED IN ALLERGIES), SEMAGLUTIDE (ADVERSE REACTION), METFORMIN, SAXENDA (ADVERSE REACTION), LAMOTRIGINE. PATIENT ALSO HAD A GASTRIC SLEEVE PLACED (B)(6) 2020 AND DIDN'T SEE MUCH PROGRESS WITH THIS." THIS IS THE PREVENTABLE ADVERSE EVENT (PAE) FOR THE GASTRIC SLEEVE. REPORTED BY HEALTHCARE PROFESSIONAL (HCP) OFFICE. HEALTHCARE PROFESSIONAL (HCP) OFFICE DID NOT CONSENT TO FOLLOW UP. NO FURTHER INFORMATION/CLARIFICATION AVAILABLE. (B)(4).