MAUDE Adverse Event Report: SPATZ MEDICAL SPATZ GASTRIC BALLOON; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Lot Number 190401

Device Problem Migration (4003)

Patient Problem Injury (2348)

Event Date 04/07/2020

Event Type  Injury  

Event Description

Patient passed spatz gastric balloon in stool, damaging his rectum, after about 6 months of insertion.He is a (b)(6) citizen, and got the balloon at another clinic than ours in (b)(6).He contacted our clinic, nordic gastric balloon, in (b)(6) seeking our medical guidance.He authorized us to contact fda on his behalf.At our clinic, we stopped using this balloon, which is not yet approved by fda, but has ce-mark, meaning it's approved for use in europe, and elsewhere (australia, middle east, and south american and (b)(6)).It's not safe device.We had many cases of deflations, migration, and passage in stool, and three cases of gastric perforations.It was banned in (b)(6) in (b)(6) 2019 after two deaths.Spatz gastric balloon is not safe for use in human and we call for it's ban.Fda safety report id# (b)(4).

• Brand Name: SPATZ GASTRIC BALLOON
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): SPATZ MEDICAL; 15 cuttermill road, # 147; great neck NY 11021
• MDR Report Key: 9962140
• MDR Text Key: 187760545
• Report Number: MW5094136
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2020

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?: Yes
• Device Operator: Health Professional
• Device Lot Number: 190401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 53