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

Device Problem Leak/Splash (1354)

Patient Problems Purulent Discharge (1812); Pain (1994); Discomfort (2330)

Event Date 04/03/2019

Event Type  Injury  

Event Description

I had breast augmentation using the inplant funnel on (b)(6) 2019 by dr (b)(6) of (b)(6).I felt achy, heavy and stiff.I was unable to sit or stand without assistance for a few days.At the two week point my left breast started leaking puss.I was told both implants would need to be removed as soon as possible.I was scheduled for removal surgery the next morning.The tests indicated no bacterial infection.Dr (b)(6) investigated with the (b)(6), and determined most likely i had a reaction caused by the inplant funnel.I had to heal for weeks before i could have new implants put in the keller funnel.The second surgery was (b)(6) 2019.I had no issues with that surgery.Two extra surgeries, drainage bags, time off and restricted diet and activities is a horrible price to pay for a device that should no longer be in use.Incidents like mine have been reported for months.There's no excuse for this happening to me.Fda safety report id# (b)(4).

• Brand Name: INPLANT FUNNEL
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): PROXIMATE CONCEPTS LLC
• MDR Report Key: 8939688
• MDR Text Key: 156255750
• Report Number: MW5089381
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 58