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

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Unspecified Infection (1930)

Event Date 05/22/2020

Event Type  malfunction  

Event Description

I performed an uneventful breast augmentation on this patient on (b)(6) 2020 and used the inplant funnel to insert her implants per the manufacturer's instructions.On pod#17, she noticed that her left breast incision developed a pinhole incision that started draining brownish fluid.I took her back to the operating room for washout and implant replacement.I had a similar situation happen to two other patients a week prior and then on 2 of my other breast augmentations done of the same day as this patient.I now strongly believe it's the result of some sort of contamination of the inplant funnel.This patient and another have grown out serratia marcescens.Fda safety report id# (b)(4).

• Brand Name: INPLANT FUNNEL
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): INPLANT FUNNEL; 1566 lemoine ave; fort lee NJ 07024
• MDR Report Key: 10178834
• MDR Text Key: 196137612
• Report Number: MW5095100
• 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: Physician
• Type of Report: Initial
• Report Date: 06/17/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: No
• 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
• Patient Age: 36 YR
• Patient Weight: 61