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

Catalog Number	1201520
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Fistula (1862); Impaired Healing (2378)
Date of Event	03/04/2019
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.This mdr represents the phasix st mesh (device 2).An additional supplemental emdr was submitted to represent the bard flat mesh (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) 2007 ¿ patient was diagnosed with incisional hernia thereby underwent open repair with the implant of bard flat mesh (device 1).Per op notes, ¿hernia sac was identified.The bard flat mesh (device 1) was placed on top of primary repair and secured with the previously placed circumferential transfascial sutures.¿ on (b)(6) 2018 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the partial removal of mesh (device 1) and implant of phasix mesh (device 2).Per op notes, ¿the patient was noted to have a subxiphoid recurrent hernia approximately baseball in size above the level of the previously placed onlay marlex mesh.Bowel was stuck to a small hernia between mesh and fascia.The mesh was still adherent to fascia was left in place and the redundant mesh (device 1) excised where fascia had pulled away.Adhesion to the anterior abdominal wall were all taken down.Free floating mesh (device 1) was also excised.An phasix mesh (device 2) was placed underlay in intraperitoneal with coated side facing the bowel using sutures.¿ on (b)(6)2018 ¿ patient was diagnosed with nonhealing surgical wound thereby underwent local debridement and excision of mesh (device 1).Per op notes, ¿the patient had a chronically nonhealing wound.Nonhealing fibrinous tissue and mesh (device 1) was excised on circumference base of the wound along with fistula tract.Several sutures were removed.The phasix mesh (device 2) was intact and appeared to be well incorporated.¿ on (b)(6) 2019 ¿ patient was diagnosed with nonhealing abdominal wound thereby underwent removal of mesh (device 2).Per op notes, ¿a small area of mesh (device 2) was noted along the side which appeared incorporated was removed.¿.

• 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: 24597085
• Report Number: 1213643-2026-00331
• Device Sequence Number: 13120165
• Product Code: OWT
• UDI-Device Identifier: 00801741095351
• UDI-Public: (01)00801741095351
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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 Catalogue Number: 1201520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 69 YR
• Patient Sex: Female