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 Codes	Scar Tissue (2060); Hernia (2240)
Date of Event	08/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided at this time, no conclusion can be made as to the degree to which the mesh implant may have caused or contributed to the patient's recurrent hernia.As reported the patient has recovered from the revision procedure.Should additional information be provided, a supplemental mdr will be submitted.The adverse reaction section of the instructions for use identifies recurrence as a possible complication, additionally the warning section states, "to prevent recurrences when repairing hernias, the phasix¿ mesh must be large enough to provide sufficient overlap beyond the margins of the defect.Careful attention to mesh fixation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue." note: 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.No sample.
Event or Problem Description
As reported per clinical study coordinator: on (b)(6) 2016 the patient underwent repair of a "first time recurrence incisional midline hernia." a retro-rectus without component separation technique was performed.Drains were placed on the right upper and left lower quadrant.The drains were removed on (b)(6) 2016.A year later on (b)(6) 2017 the patient presented for her 12 month follow up examination with suspicion of hernia recurrence.On (b)(6) 2017 the patient underwent a ct scan which revealed a recurrent hernia.On (b)(6) 2017 the patient underwent repair of the hernia recurrence.This was performed in open fashion.A sandwich technique was performed with two unspecified permanent meshes.The health professional notes there was scar formation induced by the phasix and remnants of the phasix could be seen.The patient is noted to have recovered.This hernia recurrence was assessed per the health professional as a serious adverse event being possibly related to the device and possibly related to the procedure.

• 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: 6908523
• Report Number: 1213643-2017-00645
• Device Sequence Number: 699586
• Product Code: OOD
• UDI-Device Identifier: 00801741077685
• UDI-Public: (01)00801741077685(17)170728(10)HUZG0015
• Combination Product (Y/N): N
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/02/2017

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: 07/28/2017
• Device Catalogue Number: 1190300
• Device Lot Number: HUZG0015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 10/02/2017
• 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: 68 YR
• Patient Weight: 84