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

Catalog Number	1190500
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Fasciitis (2375)
Date of Event	03/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided we are unable to determine to what extent, if any, the phasix mesh may have caused or contributed to the patient's post operative complications.At this time no conclusions can be made.Pain and inflammation are listed in the adverse reaction section of the instructions-for-use as possible complications.A review of the manufacturing records was performed.No manufacturing issues associated to the reported event were found in the reviewed lot.Dhr review showed component acceptability and traceability were confirmed through incoming inspection records for traceable components used.All process steps were completed per manufacturing and inspection procedures.Product passed all required inspections at each step at end product level.There was no rework or other manufacturing abnormalities that may have contributed to this complaint.Should additional information be provided, a supplemental emdr will be submitted.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.Remains implanted.
Event or Problem Description
The following is associated with a patient who is part of a clinical study: on (b)(6) 2017 - the patient underwent the repair of a primary incisional midline hernia with multiple midline defects and was implanted with a phasix mesh.A retro-rectus with component separation technique (posterior technique) was performed.The hernia defect measured 14cm in length and 4cm in width with swiss cheese configuration and multiple discreet hernias.The hernia site was assessed as clean contaminated and classified as vhwg grade 3 due to take down of ileostomy with ileocolonic anastomosis and created of a stoma.The mesh was fixated with 6 fixation points using mechanical fixation.On (b)(6) 2018 - the patient was diagnosed with chronic inflammation and fasciitis on the underlying mesh.This ae has been assessed by the clinician as mild in severity, possibly related to the device and possibly related to the procedure.The patient was sent for a ct scan of the abdomen and a consultation with a pain therapist.This condition is ongoing and will be re-evaluated at a later date by the clinician.

• 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: 7581731
• Report Number: 1213643-2018-01860
• Device Sequence Number: 1758973
• Product Code: OOD
• UDI-Device Identifier: 00801741077708
• UDI-Public: (01)00801741077708
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2018

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: 09/28/2018
• Device Catalogue Number: 1190500
• Device Lot Number: HUAV0563
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 06/08/2018
• 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: 48 YR
• Patient Weight: 70