UNKNOWN SALINE IMPLANTS TEXTURED UNK_SALINE IMPLANTS TEXTURED

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for UNKNOWN SALINE IMPLANTS TEXTURED UNK_SALINE IMPLANTS TEXTURED manufactured by Mentor Texas.

Event Text Entries

[185864496] At the time of this report, mentor has received no information regarding explantation or an expected explantation date. It is unknown at this time if the device will be made available for return. As a result, 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. Since no lot number was provided, no manufacturing record evaluation review could be performed. Reason for device explant and/or reoperation: na. Manufacturer? S reference number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[185864497] It was reported that a female patient underwent a primary breast augmentation with an unspecified mentor textured saline implant and experienced postoperative right-sided deflation. At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1645337-2020-05112
MDR Report Key9908470
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-09
Date of Event2019-11-01
Date Mfgr Received2020-03-09
Date Added to Maude2020-03-31
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 NameUNKNOWN SALINE IMPLANTS TEXTURED
Generic NamePROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
Product CodeFWM
Date Received2020-03-31
Catalog NumberUNK_SALINE IMPLANTS TEXTURED
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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. Other 2020-03-31

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