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 Codes	Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240)
Date of Event	08/15/2019
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-nov-2017) is considered to be a best estimate.This emdr was submitted to represent the phasix mesh (device #2).An additional supplemental emdr was submitted to represent the ventrio st (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.
Event or Problem Description
Per information provided: (b)(6) 2013 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of ventrio st mesh (device #1).Per operative notes, ¿hernia sac in mid abdomen was identified and dissected down to edges of fascia.A ventrio st mesh (device #1) was placed over the defect and sutured and stapled.¿ (b)(6) 2016 ¿ patient was diagnosed with incarcerated recurrent incisional hernia and abdominal pain thereby underwent open repair with removal of ventrio st mesh (device #1) and implant of synthetic mesh.Per operative notes, ¿dense adhesions were removed.The mesh (device #1) appeared to be contracted, indurated.The mesh (device #1) was removed.The recurrent incisional hernia was identified and sac was dissected and synthetic mesh was placed and sutured.¿ (b)(6) 2016 ¿ patient was diagnosed with incarcerated recurrent incisional hernia thereby underwent open repair.Per operative notes, ¿in lower midline, dense scar tissue with adhesions around hernia sac was excised.The recurrent hernia was repaired with sutures.¿ (b)(6) 2017 ¿ patient was diagnosed with ventral incisional hernia thereby underwent open repair with implant of synthetic mesh.(b)(6) 2018 ¿ patient was diagnosed with recurrent ventral hernia and seroma of abdomen thereby underwent open repair with removal of synthetic mesh (x2) and implant of phasix flat mesh (device #2).Per operative notes, ¿in the midline, a seroma with murky fluid was encountered.The synthetic mesh was removed and adhesions were lysed.The recurrent hernia was noted and repaired with phasix flat mesh (device #2) and sutured.¿ (b)(6) 2019 ¿ patient was diagnosed with recurrent ventral hernia and chronic abdominal pain thereby underwent open repair with implant of phasix flat mesh (device #3).Per operative notes, ¿symptomatic enlarging ventral defect in midline was identified.Hernia sac was identified and dissected.Minimal adhesions and scar tissues were removed.Flaps were raised and hernia defect was identified and phasix flat mesh (device #3) was placed on posterior rectus sheath.The anterior myofascial abdominal wall was closed over submuscular mesh (device #2) as sandwich repair and then repaired.¿.

• 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: 22563106
• Report Number: 1213643-2025-00662
• Device Sequence Number: 9219826
• Product Code: OOD
• UDI-Device Identifier: 00801741077692
• UDI-Public: (01)00801741077692(17)191228(10)HUBY1222
• 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): 07/15/2025

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: 12/28/2019
• Device Catalogue Number: 1190400
• Device Lot Number: HUBY1222
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2017
• 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: 56 YR
• Patient Sex: Female