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

Catalog Number	0115611
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	01/16/2018
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 modified onflex mesh may have caused or contributed to the patient's post operative course.The issue was corrected during the revision procedure and there has been no additional issues reported.At this time no conclusion can be made.Regarding recurrence the warning section of the instructions-for-use states, "to prevent recurrences when repairing hernias, the mesh should be large enough to provide sufficient overlap beyond the margins of the defect.If fixation is used, careful attention to mesh fixation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue." a review of the manufacturing records was performed and found that the lot was manufactured to specification.Should additional information be obtained, 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.
Event or Problem Description
It was reported that on (b)(6) 2018 the patient underwent the repair of a bilateral inguinal hernia (direct).The surgeon reports the procedure was ¿perfectly adequate¿ and ¿felt the mesh was placed well.¿ as reported the next day the patient underwent a revision procedure for the left sided repair.It is reported that the "medial inferior quadrant was ¿folded¿ allowing sac under mesh to direct defect.This was corrected, and mesh left in situ.".

• Brand Name: MODIFIED ONFLEX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7754425
• Report Number: 1213643-2018-02624
• Device Sequence Number: 1719858
• Product Code: FTL
• UDI-Device Identifier: 00801741095405
• UDI-Public: (01)00801741095405
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K142706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2018

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: 11/28/2018
• Device Catalogue Number: 0115611
• Device Lot Number: HUZK0136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 08/06/2018
• 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: 39 YR