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

Catalog Number	0117009
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusion can be made as to the degree to which the mesh implant may have caused or contributed to the hernia recurrence.As reported four years post implant the patient underwent a revision procedure to repair the recurrent hernia and is currently experiencing no further complications.Recurrence is a known inherent risk of hernia repair surgery and is listed in the adverse reaction section of the instructions-for-use as a possible complication.To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in march, 2012.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 on (b)(6) 2012 the patient underwent a hernia repair procedure and was implanted with a bard/davol soft mesh.As reported in 2016 the patient went to urgent care due to "extreme pain" in the area of the hernia repair that "brought him to his knees." at this time the doctor suspected a hernia recurrence but the surgeon found no hernia.On (b)(6) 2019 the patient underwent surgery to repair a recurrent hernia.The soft mesh was not removed and another, unspecified mesh was placed on top.As reported the surgeon told the patient that the soft mesh had "failed" but could not be removed as it had grown into the tissues.On (b)(6) 2019 the patients postoperative follow up finds the wound healing as expected with no further complications.

• Brand Name: BARD SOFT 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: 9005599
• Report Number: 1213643-2019-08667
• Device Sequence Number: 14108929
• Product Code: FTL
• UDI-Device Identifier: 00801741030864
• UDI-Public: (01)00801741030864
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2019

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: 03/28/2017
• Device Catalogue Number: 0117009
• Device Lot Number: HUWC1051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/12/2019
• 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