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

Catalog Number	1200011
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Unspecified Infection (1930); Necrosis (1971); Impaired Healing (2378)
Date of Event	03/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2007 - patient was diagnosed with abdominal wall hernia thereby underwent open repair with implant of ventralex mesh (device 1).Per op notes, ¿two hernia sac were identified and excised.A large hernia was repaired using ventralex mesh (device 1) and sutured.Another defect was repaired using sutures.¿ (b)(6) 2012 - patient was diagnosed with infected mesh and non-healing wound thereby underwent open repair with partial excision of ventralex mesh (device 1).Per op notes, ¿small amount of pus was obtained.Tissue and portions of infected old mesh (device 1) were excised.The infected tissues were debrided.The remaining old mesh edges were sutured.¿ (b)(6) 2018 - patient was diagnosed with complicated wound, infected mesh and recurrent incisional hernia thereby underwent open repair with excision of ventralex mesh (device 1) and implant of phasix st (device 2).Per op notes, ¿the infected mesh, abdominal wall and fascia were noted.Intra-abdominal adhesions were lysed.The necrotic fascia was excised.The surrounding infected tissues and old mesh (device 1) with pus were excised entirely.The hernia defect was identified and repaired with phasix st (device 2) using sutures.¿ (b)(6) 2018 - patient was diagnosed with non-healing wound thereby underwent open repair.Per op notes, ¿the necrotic subcutaneous fat and fascia were removed.¿ (b)(6) 2018 - patient was diagnosed with non-healing abdominal wound thereby underwent open repair with partial excision of phasix st (device 2).Per op notes, ¿the old mesh (device 2) that was not ingrown into the surrounding tissue was cut away.The subcutaneous tissues were excised.¿ (b)(6) 2018 - patient was diagnosed with non-healing abdominal wound thereby underwent open repair with partial excision of phasix st (device 2).Per op notes, ¿medium amount of serosanguineous drainage.Some pieces of mesh (device 2) and subcutaneous tissue were removed.¿ (b)(6) 2018 - patient was diagnosed with chronic ulcer thereby underwent open repair with partial excision of phasix st (device 2).Per op notes, ¿a small amount of exudate was noted and drained.The remnants of non-dissolved mesh (device 2) were cut out.¿ (b)(6) 2018 - patient was diagnosed with open abdominal wound thereby underwent open repair with partial excision of phasix st (device 2).Per op notes, ¿small amount of serosanguineous drainage.The exposed mesh (device 2) was cut away with subcutaneous tissues.¿ (b)(6) 2018 - patient was diagnosed with open abdominal wound thereby underwent open repair with partial excision of phasix st (device 2).Per op notes, ¿medium amount of serosanguineous drainage.The adherent slough and minimal amount of mesh was excised.¿ (b)(6) 2018 - patient was diagnosed with open abdominal wound thereby underwent open repair with partial excision of phasix st (device 2).Per op notes, ¿the scar, subcutaneous tissue and portions of mesh were excised.¿ (b)(6) 2018 - patient was diagnosed with open abdominal wound thereby underwent open repair with excision of phasix st (device 2).Per op notes, ¿the exudate was drained.Removing all remnants pieces of the mesh (device 2).The subcutaneous tissues were excised.¿.
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-may-2017) is considered to be a best estimate.This emdr represents the phasix st mesh (device #2).An additional supplemental emdr was submitted to represent the ventralex 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: 23013759
• Report Number: 1213643-2025-00821
• Device Sequence Number: 13148333
• Product Code: OWT
• UDI-Device Identifier: 00801741095283
• UDI-Public: (01)00801741095283(17)190528(10)HUBS1904
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 08/22/2025

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: 05/28/2019
• Device Catalogue Number: 1200011
• Device Lot Number: HUBS1904
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2017
• 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: Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 91 KG