INPLANT FUNNEL IN-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-24 for INPLANT FUNNEL IN-001 manufactured by Proximate Concepts, Llc.

Event Text Entries

[121724892] Mastitis - unk etiology resulting from breast augmentation on (b)(6) 2018; 1 day post surgery, using inplant funnel surgical sleeve, pt with signs and symptoms of rash / itching which resolved, at about 1. 5 weeks post, there was purulence from wound. Pt admitted to (b)(6) and treated with iv antibiotics then had course of oral antibiotics. (two other separate incidents possibly related to use of this medical device; 2 other separate reports submitted to fda, describing the incidents. )
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5080078
MDR Report Key7905771
Date Received2018-09-24
Date of Report2018-09-10
Date of Event2018-06-01
Date Added to Maude2018-09-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameINPLANT FUNNEL
Generic NameKIT, SURGICAL INSTRUMENT, DISPOSABLE
Product CodeKDD
Date Received2018-09-24
Model NumberIN-001
Lot Number042018
Device Expiration Date2019-04-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerPROXIMATE CONCEPTS, LLC
Manufacturer AddressFORT LEE NJ US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2018-09-24

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