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

Lot Number 042020

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Fluid Discharge (2686)

Event Date 05/22/2020

Event Type  Injury  

Event Description

I performed an uneventful breast augmentation on this (b)(6) y/o patient on (b)(6) 2020 and used the inplant funnel to insert her breast implants per the manufacturer's instructions.On pod#16, she presented with bilateral breast pain and draining wounds.I took her back to the operating room for washout and implant replacement.I had an almost exact situation happen on 4 of 8 breast augmentations i performed during a 1 week period.Cultures were taken from all implant pockets and none have grown bacteria.After discussion with other surgeons that had a similar experience with their patients during this time period, the inplant funnel was the only commonality among all cases (different surgeons, different facilities, different cities, different implant manufacturers, different irrigation solutions).Therefore, i strongly believe this problem is the result of some sort of contamination of the inplant funnel.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: 10179221
• MDR Text Key: 196136191
• Report Number: MW5095116
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 042020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2020
• 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): Required Intervention
• Patient Age: 22 YR
• Patient Weight: 66