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

Catalog Number	1201015
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fistula (1862); Fluid Discharge (2686)
Date of Event	05/17/2018
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-jan-2018) is considered to be a best estimate.This emdr represents the bard phasix st mesh (device # 2).An additional supplemental emdr was submitted to represent the mesh - composix kugel (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: on (b)(6) 2006 ¿ patient was diagnosed with large ventral hernia thereby underwent open repair with the implant of composix kugel mesh (device # 1).Per op notes, ¿the hernia defect in the upper abdomen was repaired using a large oval composix kugel mesh (device # 1) and anchored using sutures.¿ on (b)(6) 2015 ¿ patient was diagnosed with ring break thereby underwent open repair with partial removal of broken mesh (device # 1).Per op notes, ¿two ends of the broken ring of the composix kugel mesh (device # 1) were identified and mesh material appeared to bunch up in the periumbilical area.Then, two portions of ring were removed and most of ring was left in place.¿ on (b)(6) 2017 ¿ patient underwent colonoscopy with biopsy due to adherent suture material.On (b)(6) 2018 ¿ patient was diagnosed with enterocutaneous fistula, recurrent ventral hernia and contaminated mesh erosion thereby underwent open repair with the removal of mesh (device # 1) and implant of phasix st (device # 2).Per op notes, ¿the mesh (device #1) contracted and folded onto itself had eroded into bowel at ileocolic anastomosis.There were numerous loops of small bowel stuck to the underside of the mesh and matted to each other, forming the back wall of the fluid collection.Adhesion between small bowel and mesh taken down.The mesh (device # 1) was removed, and small bowel was divided.The ventral hernia was reinforced with phasix st mesh (device # 2) into peritoneal cavity and sutured." on (b)(6) 2018 ¿ patient was diagnosed with enterocutaneous fistula thereby underwent open repair with the removal of mesh (device # 2).Per op notes, ¿enteric appearing fluid was noted between the mesh and the overlying fascia.The mesh (device # 2) was detached from the overlying fascia and removed.Multiple adhesions were taken down and small bowel resection was performed.A synthetic mesh was placed into peritoneal cavity and sutured.¿.

• Brand Name: PHASIX ST 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: 22532640
• Report Number: 1213643-2025-00650
• Device Sequence Number: 7425317
• Product Code: OWT
• UDI-Device Identifier: 00801741095344
• UDI-Public: (01)00801741095344(17)200228(10)HUCN0728
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/04/2025

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: 02/28/2020
• Device Catalogue Number: 1201015
• Device Lot Number: HUCN0728
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2018
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 86 KG