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

Catalog Number	1200011
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Scar Tissue (2060); Hernia (2240)
Date of Event	08/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2017 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of composix e/x mesh (device #1).Per operative notes, ¿the hernia sac was identified and dissected.A composix oval mesh (device #1) was then placed into the abdominal cavity and secured.¿ (b)(6) 2017 - patient was diagnosed with large incisional hernia with contaminated mesh and adhesions thereby underwent repair with implant of phasix st mesh (device #2) and removal of mesh (device #1).Per operative notes, ¿the mesh (device #1) and identified and dissected from surrounding area which revealed adhesions.A phasix st mesh (device #2) was placed intraabdominally and sutured.¿ (b)(6) 2018 - patient was diagnosed with recurrent large incisional abdominal wall hernia and adhesions thereby underwent open repair with implant of composix e/x mesh (device #3) and composix l/p mesh (device #4) and lysis of adhesions.Per operative notes, ¿the previously placed onlay patch (device #2) was noted to be intact and there were adhesions to the anterior abdominal cavity.A composix meshes (device #3 & #4) was placed in the area of abdominal cavity and secured in place.¿ (b)(6) 2018 - patient was diagnosed with large anterior abdominal wall abscess and contaminated mesh thereby underwent excisional debridement and irrigation of anterior abdominal wall abscess.Per operative notes, ¿there were some areas of pus pockets within the mesh which were irrigated.¿ (b)(6) 2019 - patient was diagnosed with infectious disease thereby underwent repair with explant of mesh (device #2, #3 & #4).Per operative notes, ¿the mesh was dissected away from the anterior rectus sheath.There was a larger peritoneal defect with underlying small bowel.Severe inflammation and scar tissue was noted and repaired.¿ attorney alleged that the patient had adhesions, bowel obstruction, infection, pain, hernia recurrence and emotional injuries.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per medical records review, about 9 months post implant of phasix st mesh, patient was diagnosed with bacterial infection, hernia recurrence, abscess, scar tissue and adhesions thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists infection, hernia recurrence and adhesions as possible complications.The warning section of the ifu states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device.".A review of the manufacturing records was performed and found that the lot was manufactured to specification.Note, the manufacturing date (15-mar-2017) is considered to be a best estimate.This emdr represents the bard/davol phasix st mesh (device #2).Additional supplemental emdr was submitted to represent the bard/davol composix e/x mesh (device #1).Additional emdr's were submitted to represent the bard/davol composix e/x mesh (device #3) and composix l/p mesh (device #4).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.; 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 ; 4018258495
• MDR Report Key: 21400726
• Report Number: 1213643-2025-090083
• Device Sequence Number: 8215174
• Product Code: OWT
• UDI-Device Identifier: 00801741095283
• UDI-Public: (01)00801741095283(17)190328(10)HUBQ1307
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• 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): 02/18/2025

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: 03/28/2019
• Device Catalogue Number: 1200011
• Device Lot Number: HUBQ1307
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2017
• 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: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 98 KG