MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. REALIZE ADJ GASTRIC BAND-C; IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Catalog Number	RLZB32
Medical Device Problem Codes	Disconnection (1171); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypoglycemia (1912); Failure of Implant (1924); Discomfort (2330); Unspecified Tissue Injury (4559)
Date of Event	03/01/2010
Type of Reportable Event	Serious Injury
Event or Problem Description
See attached medwatch form #mw5165900.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/26/2025.D4: batch # unk.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.A manufacturing record evaluation was performed for the finished device lot number zkhbch, and no non-conformances related to the reported complaint condition were identified.Additional information obtained: per the patient, the band was implanted on (b)(6) 2010.The patient states the band never held fluid.From (b)(6) 2018, the surgeon tried to fill the band under fluoroscopy but it wouldn't hold fluid.The band was explanted on (b)(6) 2011.Once removed, the tubing had came loose from the port.The patient began to complain to the surgeon that something was not right.In (b)(6) 2013, noticed a piece remained in the patient's body.The foreign piece in the body was confirmed by ultrasound in (b)(6) 2013.It was removed (b)(6)2013.Since removal, the patient is still losing weight and still has 12-14 bowel movements per day.Can't work due to the ongoing issues.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: REALIZE ADJ GASTRIC BAND-C
• Common Device Name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 21698889
• Report Number: 3005075853-2025-02213
• Device Sequence Number: 9282140
• Product Code: LTI
• UDI-Device Identifier: 20705036004001
• UDI-Public: (01)20705036004001(17)140228(10)ZKHBCH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2014
• Device Catalogue Number: RLZB32
• Device Lot Number: ZKHBCH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female