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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Malaise (2359); Lymphoma (3263)

Event Date 05/20/2009

Event Type  Injury  

Event Description

Lap-band failure, faulty product no longer functional.(b)(6) surgery.(b)(6).Lap-band 2009 leads to gall bladder issues, nurses confirm frequency.Arrange second procedure.Post gall bladder side effect: hernia repair done.Repair causes incisional abscess and heals as open wound cleaned and packed daily by a nurse for a month to heal.Currently faulty band.Confirmed that it does not fill nor empty.Must come out, surgery was scheduled for (b)(6) 2017.I was sick.I wanted it out.But something else interrupted.(b)(6) 2017, rare intravascular lymphoma diagnosis by (b)(6).Per rare, no joke.I am an intelligent person.I've been married and teaching for 20 years while raising wonderful young men.Lap bands are a failed product causing physical pain.Why are drs still using them? why do i have to go through pain and suffering to get it out? i've been through enough with r-chop and methotrexate chemotherapy treatments.Fda safety report id# (b)(4).

• Brand Name: LAP BAND
• Type of Device: IMPLANT, INSTRAGASTRIC FOR MORBID OBESITY
• MDR Report Key: 8612995
• MDR Text Key: 145349177
• Report Number: MW5086665
• 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: 05/12/2019

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: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 45 YR
• Patient Weight: 131