MAUDE Adverse Event Report: ALLERGAN LAP BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problem Material Erosion (1214)

Patient Problems Hemorrhage/Bleeding (1888); Hypoglycemia (1912); Laceration(s) (1946); Seizures (2063)

Event Date 04/01/2006

Event Type  Injury  

Event Description

Patient called to report the adverse effects she experienced after she had a lap band implant.She said the implant eroded and cut her stomach in half.As a result, she had a massive bleeding that necessitates a lot of blood transfusions.Then she said they had to remove her whole stomach about 3 years ago in may.Currently she experiences seizure, her sugar drops a lot, so she always wears blood glucose monitor.As a result of these complications she said she cannot drive, she cannot work.She said she sent email to the manufacturer but has not heard from them yet.

• Brand Name: LAP BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 10396623
• MDR Text Key: 202909540
• Report Number: MW5096047
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/11/2020

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?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 82