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

Catalog Number	1190200
Medical Device Problem Codes	No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Bacterial Infection (1735); Unspecified Infection (1930); Not Applicable (3189)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that post-implant of the phasix mesh, the patient developed tunneling sinus tracts with wound dehiscence and had surgical intervention for mesh removal.Based on the information provided it is unclear as to the degree to which the phasix mesh may have caused or contributed to the patient¿s postoperative course.No lot number has been provided; therefore, a review of the manufacturing records is not possible.The instructions-for-use (ifu) supplied with the device lists infection and wound dehiscence as possible complications.In regards to the infection, 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." should additional information be provided, a supplemental emdr will be submitted.Not returned.Mesh explanted.
Event or Problem Description
As reported, the patient was implanted with a phasix 4x6 in (10x15cm) mesh using diep (deep inferior epigastric perforators) procedure in the abdomen, where an incision was made, natural tissue was removed and muscle was disrupted.The mesh was not placed as an onlay but deep in the facia to reinforce the area of disruption, to prevent bulge and for tissue reinforcement.It was reported the issue occurred around 6-12 weeks post operation, the patient developed tunneling sinus tracts to the mesh, the wound dehisced and had surgical intervention where the mesh was removed.The culture was positive for bacteria.
Additional Manufacturer Narrative
It was reported that post-implant of the phasix mesh, the patient developed tunneling sinus tracts with wound dehiscence and had surgical intervention for mesh removal.Based on the information provided it is unclear as to the degree to which the phasix mesh may have caused or contributed to the patient¿s postoperative course.No lot number has been provided; therefore, a review of the manufacturing records is not possible.The instructions-for-use (ifu) supplied with the device lists infection and wound dehiscence as possible complications.In regards to the infection, 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." h.11: this is an addendum to the initial emdr submitted.This supplemental emdr is submitted to confirm that the adverse event was reported in error.The contact initially sited six patient events (same condition).As such six complaints/emdr were processed.In follow up the contact confirmed only four patients had issue with one patient having two implants placed.As such this semdr is sent to correct the information previously submitted to fda.H3 other text : not returned - mesh explanted.
Event or Problem Description
As reported, the patient was implanted with a phasix 4x6 in (10x15cm) mesh using diep (deep inferior epigastric perforators) procedure in the abdomen, where an incision was made, natural tissue was removed and muscle was disrupted.The mesh was not placed as an onlay but deep in the facia to reinforce the area of disruption, to prevent bulge and for tissue reinforcement.It was reported the issue occurred around 6-12 weeks post operation, the patient developed tunneling sinus tracts to the mesh, the wound dehisced and had surgical intervention where the mesh was removed.The culture was positive for bacteria.Addendum: information provided identifies the event was erroneous.

• 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
• MDR Report Key: 10606646
• Report Number: 1213643-2020-08917
• Device Sequence Number: 14064846
• Product Code: OOD
• UDI-Device Identifier: 00801741077678
• UDI-Public: (01)00801741077678
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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: 1190200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention