MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Phasix Mesh; Surgical Mesh

Catalog Number	1190200
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	06/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2017 - patient was diagnosed with left and right inguinal hernias and umbilical and incarcerated ventral hernias thereby underwent laparoscopic and open repair with implant of 3dmax (device 1 and 2) and synthetic mesh.Per op notes, "on the left inguinal region, a large direct hernia was identified and reduced.An indirect hernia was identified and reduced.A 3dmax (device 1 - left) was placed and tacked.On the right inguinal region, a direct and indirect hernia sacs were identified and reduced.A 3dmax (device 2 - right) was placed and tacked.Periumbilical defect and umbilical defect were noted with incarcerated omentum were reduced.A synthetic mesh was placed and sutured." (b)(6) 2017 - patient was diagnosed with infection and inflammatory reaction due to prosthetic device in the abdominal wall thereby provided with antibiotics.(b)(6) 2017 - patient was diagnosed with chronic abdominal wall wound infection with mesh thereby underwent open repair with excision of synthetic mesh.Per op notes, "sinus draining was opened and drained.Dissection carried to the fascia and identified the synthetic mesh.The synthetic mesh was removed.The fascia was closed with sutures." (b)(6) 2018 - patient was diagnosed with ventral hernia thereby underwent open repair with implant of phasix flat mesh (device 3).Per op notes, "midline incision was made.The hernia sac was identified and dissected.The sac was excised.The contents were reduced.A phasix flat mesh (device 3) was placed and sutured." (b)(6) 2019 - patient had abdominal pain and underwent ultrasound/x-ray and hernia repair.
Additional Manufacturer Narrative
Root cause is inconclusive; no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the date of event (15-jun-2019) and manufacturing date (15-oct-2016) are considered to be a best estimate.This emdr represents the phasix flat mesh (device 3).An additional supplemental emdr was submitted to represent the 3dmax mesh (device 1).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: Phasix Mesh
• Common Device Name: Surgical Mesh
• Manufacturer (Section D): Davol Inc., Sub. C.R. Bard, Inc. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): Bard Shannon Limited -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; +1(800)556-6756
• MDR Report Key: 50050314
• Report Number: 1213643-2026-00949
• Device Sequence Number: 9617300
• Product Code: OOD
• UDI-Device Identifier: 00801741077678
• UDI-Public: (01)00801741077678(17)181028(10)HUAX0191
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2018
• Device Catalogue Number: 1190200
• Device Lot Number: HUAX0191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female