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

Catalog Number	1190300
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	10/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusion can be made.As reported, the reason for the hernia recurrence was "poor healing/poor adhesion development." based on the information provided at this time,we are unable to determine to what degree, if any, the mesh implant used to treat the patient may have caused or contributed to the patient's condition and hernia recurrence.Recurrence is a known inherent risk of hernia repair surgery with or without the use of mesh.Recurrence is listed in the adverse reaction section of the instructions-for-use as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be provided, a supplemental emdr will be submitted.The information provided by bard 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 bard.Not returned.
Event or Problem Description
It was reported that a patient who is part of a clinical study ((b)(46)) experienced a hernia recurrence on (b)(6) 2015 - the subject patient underwent the repair of a midline incisional hernia using the phasix mesh.Absorbable monofilament sutures were used to fixate the mesh and the fascia/skin were fully closed.On (b)(6) 2017 - the subject patient was diagnosed with a recurrent midline incisional hernia.This adverse event was assessed at this time, as moderate in severity, possibly related to the study device and possibly related to the index procedure.On (b)(6) 2018 - the subject patient underwent repair of the recurrent hernia (primarily with no mesh), with explant of the phasix mesh.The fascia/skin were fully closed.As reported, the reason for the hernia recurrence was "poor healing/poor adhesion development.".

• 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: 8037027
• Report Number: 1213643-2018-03835
• Device Sequence Number: 1643361
• Product Code: OOD
• UDI-Device Identifier: 00801741077685
• UDI-Public: (01)00801741077685
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other,stu
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2018

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: 11/28/2015
• Device Catalogue Number: 1190300
• Device Lot Number: HUXKTP21
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 11/05/2018
• 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
• Patient Age: 42 YR
• Patient Weight: 75