MAUDE Adverse Event Report: OBTECH MEDICAL SARL_ GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number BD3XV

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.

Event Description

It was reported from a customer the patient has not been subjected to port replacement, but the opening / closing system is proving to be ineffective.There are no other details available at this time.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).A device history record (dhr) review was performed by the customer quality engineer on the 06 june 2016, and no discrepancies were recorded during the manufacturing process in relation to the alleged issue.

Manufacturer Narrative

(b)(4).

• Brand Name: GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA
• 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: kathy rice ; 4545 creek rd; cincinnati, OH 45242-2803 ; 5133373299
• MDR Report Key: 5680738
• MDR Text Key: 46018553
• Report Number: 3005992282-2016-00012
• Device Sequence Number: 1
• Product Code: LTI
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/26/2010

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: 20217032
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2016
• Initial Date FDA Received: 05/25/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/31/2016; 05/31/2016; 06/06/2016; 06/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2009
• 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