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

Catalog Number RLZB22

Device Problem Connection Problem (2900)

Patient Problem Unknown (for use when the patient's condition is not known) (2202)

Event Type  malfunction  

Manufacturer Narrative

(b)(4): information unavailable.

Event Description

It was reported by an anonymous calller, the realize gastric band implanted on unknown date and the band is not connected, evidenced by x-rays taken.The patient's doctor is recommending another procedure to remove the current band and replace it.No other information is available at this time.

• Brand Name: REALIZE ADJ GASTRIC BAND STR
• 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: kathy rice ; 4545 creek rd; cincinnati, OH 45242-2803 ; 5133373299
• MDR Report Key: 3579414
• MDR Text Key: 18767563
• Report Number: 3005992282-2014-00006
• 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: 12/23/2013

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: RLZB22
• Other Device ID Number: BATCH #: UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2013
• Initial Date FDA Received: 01/16/2014
• 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
• Patient Sequence Number: 1