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

Catalog Number	1190400
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	06/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2002 - patient was diagnosed with incisional hernia thereby underwent open repair with implant of bard flat mesh (device #1) and composix mesh (device #2).Per op notes, "a bard flat mesh (device #1) and composix mesh (device #2) was placed and sutured." (b)(6) 2003 - patient was diagnosed with infected mesh thereby underwent explant of bard flat mesh (device #1) and composix mesh (device #2).Per op notes, "multiple adhesions were lysed.The bard flat mesh (device #1) and composix mesh (device #2) were excised." (b)(6) 2003 - patient was diagnosed with wound evisceration thereby underwent open repair with implant of synthetic mesh.Per op notes, "a synthetic mesh was placed and sutured." (b)(6) 2005 - patient was diagnosed with large recurrent ventral hernia thereby underwent open repair with implant of synthetic mesh.Per op notes, "a synthetic mesh was placed and sutured." (b)(6) 2009 - patient was diagnosed with large ventral hernia with fistula thereby underwent open repair with removal of synthetic meshes and implant of biological mesh.Per op notes, "the mesh adherent to the bowel was taken down.The previously placed synthetic meshes were excised.A biological mesh was placed and sutured." (b)(6) 2018 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent robotic converted to open repair with explant of biological mesh and implant of phasix mesh (device #3).Per op notes, "the biological mesh previously placed seen to be pulled away was dissected and removed.A phasix mesh (device #3) was placed and sutured." (b)(6) 2018 - patient underwent drainage of abdominal wall seroma.
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-2017) is considered to be a best estimate.This emdr represents the bard phasix mesh (device #3).Additional supplemental emdr's were submitted to represent the bard flat mesh (device #1) and bard mesh - composix (device #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 ; 8005566756
• MDR Report Key: 22370509
• Report Number: 1213643-2025-00544
• Device Sequence Number: 4437064
• Product Code: OOD
• UDI-Device Identifier: 00801741077692
• UDI-Public: (01)00801741077692(17)190928(10)HUBV1255
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 06/26/2025

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: 09/28/2019
• Device Catalogue Number: 1190400
• Device Lot Number: HUBV1255
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2017
• 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: 55 YR
• Patient Sex: Male