PHAISX FLAT MESH 1190500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,study report with the FDA on 2020-01-14 for PHAISX FLAT MESH 1190500 manufactured by Davol Inc., Sub. C.r. Bard, Inc..

Event Text Entries

[186840659] Root cause is undetermined. Based on the information provided, no conclusion can be made as to the cause of the hernia recurrence. As reported this patient has undergone multiple abdominal surgeries, including the index procedure, which included a retro-rectus placement with component separation with posterior technique utilized. No conclusions can be made at this time. Recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reaction section of the instructions-for-use as a possible complication. Should additional information be provided, a supplemental emdr will be submitted. No sample to return.
Patient Sequence No: 1, Text Type: N, H10


[186840662] It was reported to davol that a patient who is part of a clinical study experienced a hernia recurrence. On (b)(6) 2015 the subject patient underwent an open repair of a midline incisional hernia using the phasix mesh. A retro-rectus placement with component separation posterior technique was utilized. The length of the swiss cheese like defect measured 14 cm and the width measured 9 cm. Perimeter fixation was performed with absorbable monofilament suture. Twelve (12) points of fixation were made. The wound and fascia were closed. Skin was fully closed. On (b)(6) 2017 the subject patient was diagnosed with a recurrence hernia (8 x 8cm) in the same location with a ct scan performed. On (b)(6) 2017 the patient underwent additional surgery to repair the recurrent hernia. A primary repair was performed. The recurrent hernia has been assessed per the study clinician as possible related to the device and possibly related to the index procedure. The clinician has assessed the recurrence as a serious adverse event of moderate severity.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1213643-2020-00315
MDR Report Key9588218
Report SourceOTHER,STUDY
Date Received2020-01-14
Date of Report2020-01-14
Date of Event2017-06-29
Date Mfgr Received2019-12-18
Device Manufacturer Date2014-03-24
Date Added to Maude2020-01-14
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 ContactSTEVEN FIGUEROA
Manufacturer Street100 CROSSINGS BLVD.
Manufacturer CityWARWICK RI 02886
Manufacturer CountryUS
Manufacturer Postal02886
Manufacturer Phone4018258460
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 NamePHAISX FLAT MESH
Generic NameSURGICAL MESH
Product CodeOOD
Date Received2020-01-14
Model NumberNA
Catalog Number1190500
Lot NumberHUYBTP05
Device Expiration Date2016-04-30
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. Hospitalization; 2. Required No Informationntervention 2020-01-14

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