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

Catalog Number SAGBX

Device Problem Corroded (1131)

Patient Problems Unspecified Infection (1930); Nausea (1970); Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

It was reported that after the implantation of a lap band approximately 7 years ago she experienced a number of issues over the years.At first, the incision site was infected and the port used for injections for the band could not be located/was not where it was supposed to be.The healthcare provider used x-ray to locate the port.During this time the patient was also vomiting frequently.The patient then had a second surgery a "couple of years" after the first to correct the port issue, but afterwards the port was still difficult to locate when it was time for injections.The patient then reported that she experienced difficulty swallowing.The surgeon then decided to stretch the patient's esophagus.The patient continued to vomit chronically, usually a black discharge.The patient was unable to eat or drink properly.The patient then had a third surgery approximately 7-8 months ago to have the band removed.After having it removed the patient could eat and drink normally with no complications.After the removal, the patient's healthcare providers told her that the port on the lap band had become corroded.

• 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-24 00; SZ CH-2400
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 6153286
• MDR Text Key: 61699290
• Report Number: 3005992282-2016-00047
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1