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

Catalog Number	1202530
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Per medical and plaintiff profile form: (b)(6) 2020 - patient was diagnosed with parastomal hernia with obstruction, incisional hernia with multiple fascial defects with obstruction, known hostile abdomen thereby underwent robot assisted repair with the implant of ventralight st w/ echo 2 mesh (device #1).Per operative notes, ¿the hernia sac was dissected.A ventralight st w/ echo 2 mesh (device #1) placed and secure it with suture.¿ (b)(6) 2020 - patient was diagnosed with pneumoperitoneum secondary to very small enterotomy without significant intraperitoneal contamination, acute hypoxemic contamination, sever sepsis thereby underwent laparoscopic repair of enterotomy, intraperitoneal drain placement.(b)(6) 2020 - patient was diagnosed with infected abdominal wall mesh, incisional hernia, parastomal hernia, fistula, granuloma, adhesions thereby underwent open repair with explant of ventralight st w/ echo 2 mesh (device #1) and implant of phasix st mesh (device #2).Per operative notes, ¿hernia sac was dissected.Infected ventralight st w/ echo 2 mesh (device #1) was removed.Fistula, adhesions were taken down.A phasix st mesh (device #2) was placed and secure it with suture.¿ (b)(6) 2021 - patient was diagnosed with infected abdominal wall mesh, adhesions, parastomal hernia, incisional hernia, inflammation thereby underwent open repair with explant of phasix st mesh (device #2).Per operative notes, ¿hernia sac was dissected.Infected phasix st mesh (device #2) was removed.Adhesions were taken down.The defect was closed with suture.¿.
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-2019) is considered to be a best estimate.This emdr was submitted to represent the bard/davol phasix st mesh (device #2).Additional supplemental emdr represents the bard/davol ventralight st w/ echo 2 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.

• 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: 22737798
• Report Number: 1213643-2025-00734
• Device Sequence Number: 7125353
• Product Code: OWT
• UDI-Device Identifier: 00801741095375
• UDI-Public: (01)00801741095375(11)201028(10)HUDN1740
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2025

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: 10/28/2020
• Device Catalogue Number: 1202530
• Device Lot Number: HUDN1740
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2019
• 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: 64 YR
• Patient Sex: Male