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	Adhesion(s) (1695); Hernia (2240)
Date of Event	08/02/2019
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-oct-2016) is considered to be a best estimate.This emdr represents the phasix flat mesh (device 4).Additional supplemental emdrs and emdrs were submitted to represent the ventralight st mesh (device 1), ventralight st (device 2) and ventrio st (device 3).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) 2014 - patient was diagnosed with incarcerated infraumbilical and periumbilical incisional hernia thereby underwent laparoscopic repair with implant of ventralight st (device 1).Per op notes, ¿a large incarcerated incisional hernia at the level of umbilicus.The hernia was reduced.The incarcerated omentum was reduced.A ventralight st (device 1) was placed and tacked.¿ on (b)(6) 2017 - patient was diagnosed with recurrent incisional ventral hernia thereby underwent laparoscopic converted to open repair with excision of ventralight st (device 1) and implant of ventralight st (device 2), ventrio st (device 3).Per op notes, ¿the hernia sac was identified and adherent to abdominal wall.The contents of hernia sac were reduced.The failed prior mesh (device 1) was resected.The hernia sac also excised.A ventralight st (device 2) was placed and intra-abdominal cavity and secured with sutures.The ventrio st (device 3) was placed and tacked.¿ on (b)(6) 2017 - patient was diagnosed with fascial dehiscence with small bowel evisceration thereby underwent open repair with excision of ventralight st (device 2), ventrio st (device 3) and implant of phasix mesh (device 4), xenmatrix ab (device 5).Per op notes, ¿the previously placed meshes (device 2 and 3) were removed.The prior tacks were removed.A xenmatrix (device 5) was placed in the intra-abdominal cavity and secured with tacks.Phasix mesh (device 4) was placed as onlay and secured using sutures.¿ on (b)(6) 2019 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with excision of phasix mesh (device 4) and implant of biological mesh.Per op notes, ¿the hernia sac was identified and excised.Adhesions were lysed.The prior mesh (device 4) was excised.A biological mesh was placed and sutured.¿.

• 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: 23788638
• Report Number: 1213643-2025-01197
• Device Sequence Number: 13379524
• Product Code: OOD
• UDI-Device Identifier: 00801741077692
• UDI-Public: (01)00801741077692(17)181028(10)HUAX1234
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 12/11/2025

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: 10/28/2018
• Device Catalogue Number: 1190400
• Device Lot Number: HUAX1234
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2016
• 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 Age: 29 YR
• Patient Sex: Female
• Patient Weight: 151 KG