MAUDE Adverse Event Report: ALLERGAN LAP BAND

Device Problem Device Slipped (1584)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Pyrosis/Heartburn (1883); Hemorrhage/Bleeding (1888); Internal Organ Perforation (1987); Scar Tissue (2060); Burning Sensation (2146); Test Result (2695); Constipation (3274)

Event Date 02/13/2007

Event Type  Injury  

Event Description

Add'l info received on (b)(6) 2015 on report (b)(4).In addition of the pt's surgery date, mfr and serial number of the device, the name of the medicine she cannot afford is carafate, dose-1 gm/10 ml, (b)(6) for 840 mls.

Event Description

I had the lap band for 7.5 years with no problem.Then on (b)(6) the band slipped.I was having abd discomfort and was unable to go to the bathroom which i associated with my pain medication.The pain was getting worse and worse so that i finally was taken to the er.The cat scan showed i had a hole in my stomach and was having internal bleeding and had to have emergency surgery.I was transferred downtown to the main hospital where they vacuumed out my stomach, gave me a blood transfusion, and a picc line.I have decreased taste and my throat and mouth is burned form the acid.I have no health insurance and have been denied disability.I need an upper gi and a swallow test because my stomach is producing too much acid.I have scar tissue that may be closing off part of my stomach with adhesions.In (b)(6) 2014 i had 2 abscesses in my abdominal wall that was drained.

• Brand Name: LAP BAND
• Type of Device: LAP BAND
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 4483997
• MDR Text Key: 5498584
• Report Number: MW5040558
• 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,Followup
• Report Date: 02/03/2015

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: Other
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 46 YR
• Patient Weight: 88