MAUDE Adverse Event Report: OBTECH MEDICAL SARL_; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number BD3XV

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Weight Changes (2607)

Event Type  malfunction  

Event Description

It was reported that the band was implanted in 2007.At the end of 2013 the patient started to gain weight again.The surgeon suspected the esophagus had stretched.An x-ray was taken and confirmed the same and also showed the band had migrated.Some fluid was removed from the band and the band went back into place.A fill was done at this time.The band remains implanted.

Manufacturer Narrative

(b)(4): information not available, device not returned for analysis.Should the information be provided later, a supplemental medwatch will be sent.

• 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: 4107554
• MDR Text Key: 18924010
• Report Number: 3005992282-2014-00049
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BD3XV
• Device Lot Number: 20008641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/21/2014
• Initial Date FDA Received: 09/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1