MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number SAGBX

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Erosion (1750); Surgical procedure, additional (2564)

Event Date 03/01/2010

Event Type  Injury  

Event Description

The patient had the gastric band placed (b)(6) 2008.Everything was fine until (b)(6) 2010.The patient stated that she was having vomiting and stomach swelling.The patient stated that the surgeon looked at the band under fluoroscopy in his office and there was swelling and her stomach had herniated through the band.The patient stated that she was taken back to surgery ((b)(6) 2010) and she did not know for sure if the band was actually removed; she believes that the band was just fixed in this second surgery.Amount of ml¿s currently in band is unknown.The last fill she received was in (b)(6) 2014 and she thought that 1 ml was added.She stated that the doctor was aware of the restriction issue and she had asked him if there was anything in the band after the fill.She stated that the doctor could take out all that he had just put in and said ¿it¿s in there.¿ additional follow up is being conducted.If additional details become available a 3500 a supplemental will be sent.

Manufacturer Narrative

(b)(4).Information was not provided by contact.Information unavailable.Device remains implanted.

• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): OBTECH MEDICAL SARL_; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): OBTECH MEDICAL SARL; chemin-blanc 38; le locle CH-2 400; SZ CH-2400
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3758751
• MDR Text Key: 4470119
• Report Number: 3005992282-2014-00023
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 03/26/2014

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
• Device Catalogue Number: SAGBX
• Other Device ID Number: BATCH #: UNK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2014
• Initial Date FDA Received: 04/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR