MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PHASIX MESH; SURGICAL MESH

Catalog Number	1190200
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	01/08/2019
Type of Reportable Event	Serious Injury
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-feb-2016) is considered to be a best estimate.This emdr represents the bard/davol phasix mesh (device #2).Additional supplemental emdr's were submitted to represent the bard/davol ventrio st (device #1) and additional emdr was submitted to represent the bard/davol ventralex st patch (device #3).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.
Event or Problem Description
Per information provided: on (b)(6) 2016 - patient was diagnosed with left large incarcerated incisional hernia and recurrent incarcerated umbilical hernia thereby underwent open repair with the implant of ventrio st (device #1) and phasix mesh (device #2) for open left flank repair and ventralex st (device #3) for open umbilical repair.Per operative notes, "on left flank, a large hernia defect was noted.A ventral mesh was placed in circumferential fashion, another mesh (ventrio st - device #1, phasix mesh - device #2) was placed and sutured.On umbilical area, the hernia defect was noted and reduced.A ventralex st (device #3) was placed and sutured." on (b)(6) 2019 - patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with the removal of mesh (device # 1, #2) and implant of phasix st mesh (device #4).Per operative notes, "the previously placed mesh was fractured and ruptured to the external oblique.The mesh was removed.A phasix st mesh (device #4) was secured with sutures in a onlay fashion.Another piece of mesh (device #4) was secured and sutured." on (b)(6) 2019 - patient was diagnosed with ventral incisional hernia with incarcerated small bowel thereby underwent laparoscopic repair with the implant of phasix mesh with open positioning system (device #5).Per operative notes, "the hernia sac was identified and reduced.A small hernia with incarceration was noted.A phasix mesh with open positioning system (device #5) was placed.".

• 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 ; 8005566756
• MDR Report Key: 22177093
• Report Number: 1213643-2025-00460
• Device Sequence Number: 7818166
• Product Code: OOD
• UDI-Device Identifier: 00801741077678
• UDI-Public: (01)00801741077678(17)180328(10)HUAP1159
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2025

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: 03/28/2018
• Device Catalogue Number: 1190200
• Device Lot Number: HUAP1159
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2016
• 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 Age: 74 YR
• Patient Sex: Male
• Patient Weight: 84 KG