MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ REALIZE ADJ GASTRIC BAND-C; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number RLZB32

Device Problem Entrapment of Device (1212)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2014

Event Type  malfunction  

Event Description

It was reported that during a band removal and conversion to a gastric sleeve, the strain relief was found incapsulated in the sub q tissues away from the port the originally band was not implanted by this surgeon so therefore the lot number was unknown.The patient is doing fine.

Manufacturer Narrative

(b)(4): information unavailable.Device retained by account.

• Brand Name: REALIZE ADJ GASTRIC BAND-C
• 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: 3714634
• MDR Text Key: 15112970
• Report Number: 3005992282-2014-00018
• 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: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RLZB32
• Device Lot Number: ASKU
• Other Device ID Number: BATCH #: UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2014
• 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