PHASIX MESH UNKAA091

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-02-13 for PHASIX MESH UNKAA091 manufactured by Davol Inc., Sub. C.r. Bard, Inc..

Event Text Entries

[179250595] At this time no conclusions can be made. The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided. No lot number has been provided; therefore, a review of the manufacturing records is not possible. This emdr represents the bard/davol phasix mesh (device #3). Additional emdrs were submitted to represent the bard/davol composix e/x (device #1) and composix kugel hernia patch (device #2). Should additional information be provided a supplemental emdr will be submitted. Not returned.
Patient Sequence No: 1, Text Type: N, H10


[179250596] Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol composix e/x on (b)(6) 2004, composix kugel hernia patch on (b)(6) 2006 and phasix mesh on (b)(6) 2016. As reported, the patient is making a claim for an adverse patient outcome against all devices. Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device. It is also alleged that the patient experienced emotional distress and the device was defective.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1213643-2020-01192
MDR Report Key9706037
Report SourceCONSUMER,OTHER
Date Received2020-02-13
Date of Report2020-02-13
Date Mfgr Received2020-02-05
Date Added to Maude2020-02-13
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 ContactANDREW TOPOULOS
Manufacturer Street100 CROSSINGS BLVD.
Manufacturer CityWARWICK RI 02886
Manufacturer CountryUS
Manufacturer Postal02886
Manufacturer Phone4018258495
Manufacturer G1BARD SHANNON LIMITED 3005636544
Manufacturer StreetSAN GERONIMO INDUSTRIAL PARK LOT #1, ROAD #3, KM 79.7
Manufacturer CityHUMACAO PR 00791
Manufacturer CountryUS
Manufacturer Postal Code00791
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePHASIX MESH
Generic NameSURGICAL MESH
Product CodeOOD
Date Received2020-02-13
Model NumberNA
Catalog NumberUNKAA091
Lot NumberNI
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDAVOL INC., SUB. C.R. BARD, INC.
Manufacturer Address100 CROSSINGS BLVD. WARWICK RI 02886 US 02886


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-13

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