MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH 3509214

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 2020-03-05 for MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH 3509214 manufactured by Mentor Texas.

Event Text Entries

[182309605] 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


[182309606] It was reported that a (b)(6) year-old african american female patient who underwent a breast reconstruction primary with mentor cpx4 with suture tabs, med height, smooth tissue expander has experienced postoperative right-sided deflation of tissue expander. The surgeon reported that tissue expander was initially placed at 350cc, and upon the first attempt at tissue expansion, the fluid leaked out of the expander. As a result, the patient underwent explantation and replacement with unspecified mentor tissue expander on (b)(6) 2020. The patient was hospitalized for two nights, and per surgeon? S report, patient has no residual effects.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1645337-2020-03708
MDR Report Key9795390
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-05
Date of Report2020-02-11
Date of Event2020-02-11
Date Mfgr Received2020-02-11
Device Manufacturer Date2019-02-04
Date Added to Maude2020-03-05
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 NameMENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH
Generic NameEXPANDER, SKIN, INFLATABLE
Product CodeLCJ
Date Received2020-03-05
Returned To Mfg2020-02-24
Catalog Number3509214
Lot Number7682064
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 2020-03-05

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