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); Scar Tissue (2060); Hernia (2240)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6)2016 - patient was diagnosed with incisional hernia thereby underwent open repair with implant of ventralex st mesh (device 1).Per op notes, "a hernia sac in abdominal region was identified and was dissected.A ventralex st mesh (device 1) was placed into the area and sutured." (b)(6)2016 - patient was diagnosed with recurrent incisional hernia, thereby underwent open repair with implant ofventralex st mesh (device 2).Per op notes, "a small incision was made through the prior incision site.Hernia defect was identified and dissected.A ventralex st mesh (device 2) was placed and sutured." (b)(6)2017 - patient was diagnosed with recurrent incisional hernia, thereby underwent open repair with implant of phasix st mesh (device 3), phasix flat mesh (device 4).Per op notes, "through prior incision site, the mesh (device 1 and 2) was noted and was found adherent to the abdominal contents.The ventralex st mesh (device 2) was removed.A phasix st mesh (device 3) was placed into the defect as an underlay and was sutured.A phasix flat mesh (device 4) was placed as an onlay and was sutured." (b)(6)2019 - patient was diagnosed with recurrent incisional hernia, thereby underwent laparoscopic repair with implant of ventralight st mesh (device 5).Per op notes, "the existing scar tissue was removed.A hernia defect was identified and omental adhesions to anterior abdominal wall was lysed.A ventralight st mesh (device 5) was inserted into peritoneal cavity and was tacked,".
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-2016) is considered to be a best estimate.This emdr represents the phasix st mesh (device 3).Additional supplemental emdrs were submitted to represent the ventralex st mesh (device 1 & 2), phasix flat mesh (device 4) and ventralight st mesh (device 5).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 ; +1(800)556-6756
• MDR Report Key: 50837147
• Report Number: 1213643-2026-01211
• Device Sequence Number: 15967590
• Product Code: OWT
• UDI-Device Identifier: 00801741095344
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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 Expiration Date: 08/28/2018
• Device Catalogue Number: 1201015
• Device Lot Number: HUAV0321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2016
• 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 Sex: Male