MAUDE Adverse Event Report: ALLERGAN (NOW APPOLO ENDO OWNS) AP LAP BAND

Device Problems Corroded (1131); Device Slipped (1584)

Patient Problems Nausea (1970); Pain (1994); Discomfort (2330)

Event Date 01/12/2016

Event Type  Injury  

Event Description

Allergan ap lap band inserted 10 years ago.Three months ago had problems swallowing's was nauseated, had pain and discomfort in the area were the band slipped.Eventually had emergency surgery to remove the band and it was complicated and long due to the corrosion of the band and it had embedded into stomach tissue.Fifteen day hospital stay, then to skilled nursing facility.Functionality with gj tube now.This will have lasting health ramifications for me.

• Brand Name: AP LAP BAND
• Type of Device: AP LAP BAND
• Manufacturer (Section D): ALLERGAN (NOW APPOLO ENDO OWNS)
• MDR Report Key: 5398160
• MDR Text Key: 37093276
• Report Number: MW5059791
• Device Sequence Number: 1
• Product Code: LTI
• 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: 01/26/2016

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?: Yes
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: SYNTHROID
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 73 YR
• Patient Weight: 82