MAUDE Adverse Event Report: ETHICON ENDO-SURGERY INC. REALIZE GASTRIC BAND; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Device Problems Migration or Expulsion of Device (1395); Material Puncture/Hole (1504)

Patient Problems Erosion (1750); Unspecified Infection (1930); Nausea (1970); Pain (1994); Scar Tissue (2060)

Event Date 10/01/2018

Event Type  Injury  

Event Description

Had a realize lap band placed 2009.Had always had problems with fills/unfills d/t "flipped port".Had bouts of nausea and pain which were reported to md.Decided to have lap bend removed and get sleeve gastrectomy; had pre op egd done on (b)(6) which showed a "sore spot" on the stomach.Md gave me prilosec tp take until 1 month after gastrectomy.Md did diagnose band erosion nor did he remove the 5 ml fluid present in the band.Three weeks prior to my surgery on (b)(6), the fluid was removed from the band.The unfill procedure was the most painful difficult one in the 9 years of them.The sink at the port site became very red, painful and warm to touch.With much time spent on warm compresses and neosporin oint it subsided.I went in to surgery (b)(6) with surgeon coming out to me after stating how bad the erosion and scar damage and said the entire band was in the stomach.There was a large hole and md had to make a second hole to reach areas to be repaired.He stated that some people are able to wait 6 to 9 months and try a gastrectomy again after scar tissue has healed better but he voiced some doubt that this would be possible for me due to the severity of the damage.I had 5 incisions with a drain present for nearly 2 weeks with large amounts of blood drainage.The largest incision was where my port had been.It was very deep and had copious amounts of yellow green drainage with 6 times a day dressing changes.I ended up on an antibiotic for an infection at the port site.The surgeon stated the open stomach drained its bacteria up the tubing to this area which is why the infection was severe.I returned to the md 9 days later and he sliced open the small fragile layer of skin on the site to allow the large amounts of drainage to flow out.Applied neosporin and wet to dry dressing 3 to sometimes 8 times a day for 2 weeks.Six weeks after surgery i still have a 1/2 cm x 1/3 cm open hole approx.1/2 inch deep, drainage is thin bloody in moderate amounts.My entire abdominal area is quite sore with sometimes sharp stabbing pains and burning sensations.I have bouts of nausea as i did with the lap band in.

• Brand Name: REALIZE GASTRIC BAND
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY INC.
• MDR Report Key: 8074359
• MDR Text Key: 127528534
• Report Number: MW5081286
• 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: 11/13/2018

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: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 57 YR
• Patient Weight: 120