MAUDE Adverse Event Report: PROXIMATE CONCEPTS LLC INPLANT FUNNEL

Model Number IN-001

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problems Wound Dehiscence (1154); Purulent Discharge (1812); Impaired Healing (2378)

Event Date 01/16/2020

Event Type  Injury  

Manufacturer Narrative

This report is a response to medwatch report mw5095276.The initial reporter of the complaint is unknown to the manufacturer.Proximate concepts had received the complaint, but no device was returned for evaluation.Therefore we have limited information from the entity submitting the complaint.Based on the information provided, it is unknown what lot number to perform a manufacturing audit on.Proximate concepts performed an audit of relevant sterilization records and confirmed that devices shipped in the time-frame of this report were confirmed to be sterilized to documented procedures.Bioburden testing and sterilization logs confirm shipment of sterile product.As such, this file has been closed.Manufacturer's reference number: (b)(4).

Event Description

On 06/25/2020 a hcp submitted a voluntary report to the fda (mw5095276) regarding an adverse event that occurred 8 days post breast augmentation surgery.The reporter explains that 8 days after postop, the right inframammary wound opened and exposed suture.The wound began to leak fluid.The left breast developed a pinpoint hole and was draining serosanguinous fluid.Two days later both breasts were leaking and it was elected to remove both implants.

• Brand Name: INPLANT FUNNEL
• Type of Device: INPLANT FUNNEL
• Manufacturer (Section D): PROXIMATE CONCEPTS LLC; 6 pearl court; suite h; allendale NJ 07401
• Manufacturer (Section G): PROXIMATE CONCEPTS LLC; 6 pearl court; suite h; allendale NJ 07401
• Manufacturer Contact: salvatore romano ; 6 pearl court; suite h; allendale, NJ 07401 ; 2019138833
• MDR Report Key: 11805700
• MDR Text Key: 250083004
• Report Number: 3013980229-2021-70027
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IN-001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other