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

Catalog Number RLZB32

Device Problem Fracture (1260)

Patient Problem Abdominal Pain (1685)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.As the device was not returned, a device analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Additionally, the lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.Following information was requested but unavailable: is the lot number available? are the medical records available for review? what was the exact implant date? (b)(4).

Event Description

User facility medwatch form, mw # (b)(4).

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot number znbbbf, and no non-conformance were identified.

Manufacturer Narrative

(b)(4).

• Brand Name: REALIZE ADJ GASTRIC BAND-C
• Type of Device: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8596681
• MDR Text Key: 144668486
• Report Number: 3005075853-2019-18938
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: RLZB32
• Device Lot Number: ZNBBBF
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 05/09/2019
• Supplement Dates Manufacturer Received: 05/13/2019; 05/13/2019
• Supplement Dates FDA Received: 05/13/2019; 06/05/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other