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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INPLANT FUNNEL INPLANT FUNNEL; KIT, SURGICAL INSTRUMENT, DISPOSABLE
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INPLANT FUNNEL INPLANT FUNNEL; KIT, SURGICAL INSTRUMENT, DISPOSABLE Back to Search Results
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Fever (1858); Unspecified Infection (1930)
Event Date 05/15/2020
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.Starting on pod#10, she had high fevers (>102) of unknown origin.Her breasts and breast incisions were unremarkable until pod#14 when her right 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 the week prior and then on my next 3 out of 8 breast augmentations and 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).
 
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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 Key10178656
MDR Text Key196140360
Report NumberMW5095092
Device Sequence Number1
Product Code KDD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received06/19/2020
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 Number1
Patient Outcome(s) Other;
Patient Age35 YR
Patient Weight62
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