MAUDE Adverse Event Report:; GASTRIC IMPLANT, OBESITY

Device Problems Migration or Expulsion of Device (1395); Device Slipped (1584)

Patient Problem Tissue Damage (2104)

Event Date 03/03/2015

Event Type  No Answer Provided  

Event Description

Moderate sized slip of gastric band with thin/dilated gastric wall which resulted in a gastrotomy requiring full thickness repair.Port also flipped.

• Brand Name: UNK
• Type of Device: GASTRIC IMPLANT, OBESITY
• MDR Report Key: 4823686
• MDR Text Key: 5901968
• Report Number: 4823686
• Device Sequence Number: 1
• Product Code: LTI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2015
• Device Age: 7 YR
• Date Report to Manufacturer: 06/08/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2015
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 52