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

Catalog Number	1194040
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Bacterial Infection (1735); Necrosis (1971)
Date of Event	11/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.Per the medical records review, post implant of phasix mesh, patient was diagnosed with bacterial infection, necrosis and wound dehiscence thereby underwent repair.The adverse reaction section of the instructions-for-use, supplied with the device identifies infection and wound dehiscence as possible complications.Regarding infection, the warning section of the ifu states that, "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." no lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents phasix mesh (device #3).A supplemental emdr was submitted to represent ventrio mesh (device #1) and an emdr to represent phasix mesh (device #2).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.H3 other text : not returned.
Event or Problem Description
Per information provided by patient's attorney: (b)(6) -2013 - patient was diagnosed with recurrent incarcerated incisional ventral hernia thereby underwent open repair with the implant of ventrio mesh (device #1).Per operative notes, "the hernia sac was identified and excised.A ventrio mesh (device #1) was positioned into the peritoneal cavity and tacked to the anterior abdominal cavity." (b)(6) 2013 - patient was diagnosed with abdominal wall infection, cellulitis and infected mesh thereby underwent exploratory laparotomy with the removal of mesh (device #1).Per operative notes, "incision was carried down to the level of the mesh (device #1) and noted that there was a copious amount of fluid around the mesh and suctioned out.Lysis of adhesions was performed and there was noted some adherent small bowel intrabdominal content.Once, this was done the mesh (device #1) was removed." (b)(6) 2018 - patient was diagnosed with ventral hernia thereby underwent open repair with the implant of phasix meshes (device #2 & device #3).Per operative notes, ¿hernia sac was resected and a phasix mesh (device #2) was trimmed, placed and sutured to the rectus sheath.Another phasix mesh (device #3) was trimmed, placed and sutured to the external oblique of aponeurosis circumferentially.¿ (b)(6) 2018 - patient was diagnosed with abdominal post operative wound infection thereby underwent debridement of abdominal wound and wound vac placement.Per operative notes, ¿laparotomy incision had to be reopened to allow debridement.On the left side, there was extensive fat necrosis of the deep fat.There was mesh (device #3) at the base of the wound, this was a superficial mesh placed as a reinforcement.The strength layer of the mesh (device #2) in the retrorectus position was not exposed.The midline fascial closure was healing and not interrupted.All nonviable or infected tissue was removed.¿ (b)(6) 2018 - patient underwent repair for abdominal post operative wound infection and wound dehiscence.(note: there was no mention/visualization of meshes).Attorney alleged that the patient had bowel removal, infection, pain and emotional injuries.It is also alleged that patient underwent removal of mesh, abdominal wall reconstruction, debridement, wound vac placement and wound closure.

• Brand Name: PHASIX 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: 18354038
• Report Number: 1213643-2023-095245
• Device Sequence Number: 6775237
• Product Code: OOD
• UDI-Device Identifier: 00801741107689
• UDI-Public: (01)00801741107689
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

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: 11/28/2019
• Device Catalogue Number: 1194040
• Device Lot Number: HUBX0374
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 108 KG