ARTOURA BREAST TISSUE EXPANDER TEXP120RUH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-19 for ARTOURA BREAST TISSUE EXPANDER TEXP120RUH manufactured by Mentor Texas.

Event Text Entries

[184447176] Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made. As such, the investigation will be closed. If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate. A manufacturing record evaluation is in progress. Once completed, a supplemental report will be submitted. Reason for device explant and/or reoperation: unknown. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[184447177] One artoura breast tissue expander 535cc was received by the mentor failure analysis lab on 2/27/2020 with no accompanying information. The device could not be associated with an existing complaint. In the absence of clarifying information, it cannot be determined why this device was returned to mentor. However, the return of a prosthesis is characteristic of a removal and replacement surgery. As a result, this will be conservatively reported to fda.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1645337-2020-04555
MDR Report Key9855920
Report SourceOTHER
Date Received2020-03-19
Date of Report2020-02-27
Date of Event2020-02-27
Date Mfgr Received2020-02-27
Device Manufacturer Date2018-11-13
Date Added to Maude2020-03-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
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 Received2020-03-19
Returned To Mfg2020-02-27
Model NumberTEXP120RUH
Catalog NumberTEXP120RUH
Lot Number7653725
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 2020-03-19

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