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

Catalog Number	1190400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	05/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusion can be made.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 recurrent hernia.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.Remains implanted.
Event or Problem Description
It was reported that a patient who is part of a clinical study (phasix dvl-he-011) experienced a hernia recurrence on (b)(6) 2014 - the subject patient underwent repair of a midline primary incisional hernia with the implant of a phasix mesh.This was a retro-rectus repair without component separation technique.Absorbable monofilament suture was used for fixation of the mesh.The fascia and skin were fully closed.On (b)(6) 2018 - the subject patient was diagnosed with a hernia recurrence.This adverse event has been assessed as mild severity, possibly related to the device and not related to the index procedure.No action has been taken at this time, condition is listed as ongoing.

• 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: 7973590
• Report Number: 1213643-2018-03581
• Device Sequence Number: 1682525
• Product Code: OOD
• UDI-Device Identifier: 00801741077692
• UDI-Public: (01)00801741077692
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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: 12/28/2014
• Device Catalogue Number: 1190400
• Device Lot Number: HUXETP13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 10/17/2018
• 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: 52 YR
• Patient Weight: 96