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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROXIMATE CONCEPTS, LLC INPLANT FUNNEL; KIT, SURGICAL INSTRUMENT, DISPOSABLE
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PROXIMATE CONCEPTS, LLC INPLANT FUNNEL; KIT, SURGICAL INSTRUMENT, DISPOSABLE Back to Search Results
Model Number IN-001
Device Problem Contamination /Decontamination Problem (2895)
Patient Problems Unspecified Infection (1930); Inflammation (1932); No Code Available (3191)
Event Date 05/14/2020
Event Type  Injury  
Event Description
Product problem because of suspected contamination - 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 #13, she presented with a draining wound.I took her back to the operating room for washout and implant replacement.I had a similar situation happen with 5 of 8 breast augmentations between (b)(6) 2020 through (b)(6) 2020 and now strongly believe it's the result of some sort of contamination or inflammatory response due to the inplant funnel used.Fda safety report id# (b)(4).
 
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Brand Name
INPLANT FUNNEL
Type of Device
KIT, SURGICAL INSTRUMENT, DISPOSABLE
Manufacturer (Section D)
PROXIMATE CONCEPTS, LLC
fort lee NJ 07024
MDR Report Key10179079
MDR Text Key196140890
Report NumberMW5095109
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
1 Device was Involved in the Event
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
Device Model NumberIN-001
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) Required Intervention;
Patient Age37 YR
Patient Weight50
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