MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. CUR.ADJ.BAND WITH PORT+APPLIER; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number BD3XV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abscess (1690)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.Following information was requested but unavailable: what was the issue that led to the removal of the band? what is meant by operative side? is there a fill history available for review? please confirm what the white cap means?.

Event Description

Removal of the band obtech and its sternal casing.The white cap retained on subcutaneous, not found intraoperatively.Abscess on the operating side.

• Brand Name: CUR.ADJ.BAND WITH PORT+APPLIER
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9350609
• MDR Text Key: 181935140
• Report Number: 3005075853-2019-23621
• 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: foreign,other
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: BD3XV
• Device Lot Number: ZTFBBJ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other