MAUDE Adverse Event Report: INPLANT / PROXIMATE CONCEPTS LLC INPLANT FUNNEL; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Device Problem Fluid/Blood Leak (1250)

Patient Problems Fever (1858); Fluid Discharge (2686)

Event Date 01/05/2021

Event Type  Injury  

Event Description

Patient is a healthy (b)(6) year-old woman with no prior medical history who desired bilateral subgranular breast augmentation using smooth round silicone gel implants.She underwent surgery on (b)(6) 2020 without intraoperative problems during which the inplant funnel device ((b)(6)) was used to deliver bilateral smooth round mentor silicone gel implants.On (b)(6) 2020, she reported a fever and began broad-spectrum antibiotics on (b)(6) 2021.On (b)(6) 2021, she experienced drainage of brown murky fluid from the right breast incision.She was returned to the operating room on (b)(6) 2021, where she was found to have brown murky fluid around the left breast implant as well.Both implants were removed, and pockets were irrigated and closed.Culture results have not grown any bacteria.Fda safety report id # (b)(4).

• Brand Name: INPLANT FUNNEL
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): INPLANT / PROXIMATE CONCEPTS LLC; allendale NJ 07401
• MDR Report Key: 11139298
• MDR Text Key: 226318559
• Report Number: MW5098741
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 33 YR
• Patient Weight: 59