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

Catalog Number	1190500
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Seroma (2069); Hernia (2240)
Date of Event	03/04/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.About several post implant of phasix mesh, this obese patient with complex medical/surgical history was diagnosed with hernia recurrence, seroma and adhesions thereby underwent repair procedures.The instructions-for-use supplied with the device lists hernia recurrence, seroma and adhesions as possible complications.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents phasix mesh (device #2).An additional supplemental emdr was submitted to represent mesh - composix (device #1) and an emdr to represent phasix mesh (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 by patient's attorney: on (b)(6) 2007 - patient was diagnosed with several incisional hernias and incarcerated small bowel obstruction thereby underwent open repair with the implant of composix mesh (device #1).Per operative notes, "identified a large ventral hernia just to left of the umbilicus which contained a knuckle of small bowel and incarcerated omentum.The hernia defect was exposed with some omental adhesions.Several additional small incisional hernias were converted into one large midline fascial defect and removed along with adhesions.A composix mesh (device #1) was then cut to appropriate shape and sutured to the edges of the fascia circumferentially using sutures." on (b)(6) 2007 - patient was admitted with abdominal wound dehiscence, infection and abdominal pain thereby underwent drainage with wound vac.On (b)(6) 2007 - patient was diagnosed with mesh infection thereby underwent repair with removal of the mesh (device #1).Per operative notes, "the patient had an open wound with exposed hernia mesh.Mesh edges were identified and the mesh (device #1) was dissected from surface of the fascia along with the sutures.Wound vac was placed." on (b)(6) 2009 - patient was diagnosed with chronic nonhealing abdominal wound thereby underwent debridement and reconstruction of wound with a skin graft.On (b)(6) 2014 - patient was diagnosed with incisional hernia thereby underwent open repair with the implant of phasix mesh (device #2).Per operative notes, "after complete lysis of adhesions, a large hernia sac was taken down.The fascial defect was repaired with piece of biological mesh which was placed in the space under the obliques on the right, under the peritoneum on the left and sutured.To add strength a piece of phasix mesh (device #2) was placed as an onlay, sutured to lateral aspect of external oblique and drains were placed." (note, no product identifier provided for phasix mesh (device #2)) on (b)(6) 2015 - patient was diagnosed with open wound after previous incisional hernia repair thereby underwent open repair with the implant of phasix mesh (device #3) and panniculectomy.Per operative notes, "the upper part of the wound in the midline incision, flaps were created on the right and left sides, taking it off the previous phasix mesh (device #2) closure.A piece of phasix mesh (device #3) was then placed under the flaps to add additional strength to the abdominal wall and sewn in place to the fascia and wound drain was placed." on (b)(6) 2017 - patient was diagnosed with recurrent incisional hernia and adhesions thereby underwent repair with implant with biological mesh.(note, there was no mention/visualization of phasix meshes (device #2 and device #3) during this procedure) on (b)(6) 2017 to (b)(6) 2018 - patient underwent treatment of open abdominal wound and moderate amount of serous discharge was noted.Attorney alleges that patient had hernia recurrence, adhesions, mesh removal, debridement, reconstruction, pain and emotional injuries.

• 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: 18638952
• Report Number: 1213643-2024-090448
• Device Sequence Number: 15449058
• Product Code: OOD
• UDI-Device Identifier: 00801741077708
• UDI-Public: (01)00801741077708
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2024

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 Catalogue Number: 1190500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 02/05/2024
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 76 KG