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 report with the FDA on 2020-01-02 for PHASIX MESH UNKAA091 manufactured by Davol Inc., Sub. C.r. Bard, Inc..

Event Text Entries

[174179026] No conclusion can be made. As reported the patient has a complex surgical history and the information provided is limited. As such we are unable to determine the degree to which the mesh implant may have caused or contributed to the reported hernia recurrence. Hernia recurrence is a known inherent risk of hernia repair surgery and is listed in the instructions-for-use as a possible complication. A lot number was not provided; without a lot number a review of the manufacturing records is not possible. Note the date of event and date of implant are estimated based on the information provided. Should additional information be provided, a supplemental emdr will be submitted. This emdr represent the bard phasix mesh (device #1) an additional emdr was submitted to represent the bard phasix mesh (device # 2) remains implanted.
Patient Sequence No: 1, Text Type: N, H10


[174179027] It was reported that the patient had stage 3 bladder cancer in which his bladder was removed and a nephrostomy bag was placed. The patient subsequently developed an abdominal hernia. In 2017 the patient underwent repair of the ventral abdominal hernia with implant of a bard phasix mesh (device # 1). In (b)(6) 2018 the patient underwent repair of a recurrent hernia with implant of a second bard phasix mesh (device # 2). The previous phasix mesh (device #1) was not removed at this time. As reported, the patient is experiencing extreme pain and has a "bubble" where the mesh is located. The patient underwent an ultrasound recently but had not yet received the results. As reported, the pain has prevented the patient from working.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1213643-2020-00003
MDR Report Key9539784
Report SourceCONSUMER
Date Received2020-01-02
Date of Report2020-01-02
Date of Event2018-04-15
Date Mfgr Received2019-12-13
Date Added to Maude2020-01-02
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 ContactLAURA SUNDBERG
Manufacturer Street100 CROSSINGS BLVD.
Manufacturer CityWARWICK RI 02886
Manufacturer CountryUS
Manufacturer Postal02886
Manufacturer Phone4018258462
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 Received2020-01-02
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; 2. Deathisabilit 2020-01-02

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