ARTOURA BREAST TISSUE EXPANDER SMXP150RH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-30 for ARTOURA BREAST TISSUE EXPANDER SMXP150RH manufactured by Mentor Texas.

Event Text Entries

[186379139] The mentor failure analysis lab has received the device for evaluation. The analysis has begun but is not complete at this time. When the investigational analysis has been completed, a supplemental report will be submitted. A manufacturing record evaluation is in progress. Once completed, a supplemental report will be submitted. Reason for device explant and/or reoperation: deflation. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[186379140] It was reported that a (b)(6) year old caucasian female patient underwent a breast reconstruction revision with artoura breast tissue expander 750cc and experienced a deflation on the right side post-operatively, which was confirmed by a physician. As a result, the patient underwent explantation on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1645337-2020-04980
MDR Report Key9898470
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-30
Date of Report2020-03-09
Date of Event2020-03-06
Date Mfgr Received2020-03-09
Device Manufacturer Date2019-10-18
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactMR. GABRIEL ALFAGEME
Manufacturer Street3041 SKYWAY CIRCLE NORTH
Manufacturer CityIRVING TX 75038
Manufacturer CountryUS
Manufacturer Postal75038
Manufacturer Phone949789-868
Manufacturer G1MENTOR TEXAS
Manufacturer Street3041 SKYWAY CIRCLE NORTH
Manufacturer CityIRVING TX 75038
Manufacturer CountryUS
Manufacturer Postal Code75038
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameARTOURA BREAST TISSUE EXPANDER
Generic NameEXPANDER, SKIN, INFLATABLE
Product CodeLCJ
Date Received2020-03-30
Returned To Mfg2020-03-17
Model NumberSMXP150RH
Catalog NumberSMXP150RH
Lot Number9379127
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMENTOR TEXAS
Manufacturer Address3041 SKYWAY CIRCLE NORTH IRVING TX 75038 US 75038


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-30

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