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

Catalog Number	1190500
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Unspecified Infection (1930); Scar Tissue (2060)
Date of Event	07/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2012 - patient was diagnosed with recurrent ventral hernia, incarcerated incisional hernia, thereby underwent open repair with explant of synthetic mesh, implant of ventrio st mesh (device 1).Per op notes, "through a midline incision, previously placed synthetic mesh was identified and was dissected.Then a midline fascia was identified and repaired by placing a ventrio st mesh (device 1) into the defect and was sutured." (b)(6) 2013 - patient was diagnosed with recurrent incisional hernia, thereby underwent open repair with implant of ventrio st mesh (device 2).Per op notes, "hernia defect in the abdominal region was identified and was dissected.A ventrio st mesh (device 2) was placed and secured in place with sutures to the previous mesh (device 1) in the midline and was tacked to cover the entire defect." (b)(6) 2015 - patient was diagnosed with recurrent ventral hernia, thereby underwent open repair.Per op notes, "purulent drainage was noted from the middle portion of the midline incision site." (b)(6) 2016 - patient was diagnosed with abdominal pain, thereby underwent repair with implant of biologic mesh.Extensive intra-abdominal small bowel adhesive disease from prior ventral hernia mesh repair, with a quite large piece of mesh.Small bowel densely adherent to this mesh in the rlq of the abdomen and suspected to be the source of abdominal pain.(b)(6) 2017 - patient was diagnosed with chronic abdominal pain, inflammation around the intra-abdominal mesh, thereby underwent explant of ventrio st mesh (device 1 and 2), implant of phasix flat mesh (device 3).Per op notes, "scar tissue in the midline was identified.Dense adhesions were noted.The ventrio st mesh (device 1 and 2) was found turned around in few places and had adhesions which was then lysed.The ventrio st mesh (device 1 and 2) were excised.The midline fascia was then closed by placing phasix flat mesh (device 3)." (b)(6) 2017 - patient was diagnosed with chronic abdominal wall wound, thereby underwent open repair with explant of phasix flat mesh (device 3).Per op notes, "the scar tissue was identified and excised.Some portions of phasix flat mesh (device 3) might be reabsorbable.The exposed portion of the infected phasix flat mesh (device 3) was excised.".
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 manufacturing date (15-aug-2016) is considered to be a best estimate.This emdr represents the phasix flat mesh (device 3).Additional supplemental emdrs were submitted to represent the ventrio st mesh (device 1 & 2).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: 50459855
• Report Number: 1213643-2026-01114
• Device Sequence Number: 13277700
• Product Code: OOD
• UDI-Device Identifier: 00801741077708
• UDI-Public: (01)00801741077708(17)180828(10)HUAV0561
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2026

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: 08/28/2018
• Device Catalogue Number: 1190500
• Device Lot Number: HUAV0561
• 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: 08/18/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2016
• 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