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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/16/2020

Event Type  Injury  

Event Description

The patient had a breast augmentation on (b)(6) 2019.Sientra breast implants were placed and an inplant funnel was used to place the implants.At a week postop she was doing well but at 8 days the right inframammary wound opened and there was an exposed suture.The wound was sutured but over the next 24 hours the wound opened again and was leaking brownish fluid.The left breast, which looked normal with a nicely healing now had a pinpoint hole that was draining serosanguinous fluid.Two days later on (b)(6) 2020 both breasts were leaking and it was elected to remove both implants.Fda safety report id# (b)(4).

• Brand Name: INPLANT FUNNEL
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): PROXIMATE CONCEPTS LLC ; fort lee NJ 07024
• MDR Report Key: 10211717
• MDR Text Key: 197146468
• Report Number: MW5095276
• 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: Other
• Type of Report: Initial
• Report Date: 06/25/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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 Age: 30 YR
• Patient Weight: 60