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

Catalog Number	0010103
Medical Device Problem Codes	Defective Device (2588); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240); Injury (2348)
Date of Event	05/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol kugel patch (device #1) may have caused or contributed to the reported event.To date no medical records have been provided.The attorney alleges the patient underwent an additional surgery to remove the device and repair the recurrent hernia.The doctor noted ¿there is a free edge of the mesh identified inferiorly and there is slight bulging of the intraabdominal fat into the area of the mesh in a pannus-like fashion.The pattern here suggests dehiscence of the mesh attachment.¿ recurrence is a known inherent risk of surgery and is listed in the instructions-for-use a possible complication.No sample was returned.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.This emdr represents the bard/davol kugel patch (device #1).An additional emdr was submitted to represent the bard/davol ventrio (device #2).Note: not returned.
Event or Problem Description
The following was alleged by the patient's attorney: (b)(6) 2015: the patient underwent repair of a ventral incisional hernia.As alleged, a bard/davol 3x3¿ kugel patch (device #1)was implanted in patient during this repair.(b)(6) 2016: the patient underwent surgery to explant the failed mesh device and repair an incisional hernia.Prior to the surgery the doctors.Noted that ¿there is a free edge of the mesh identified inferiorly and there is slight bulging of the intra-abdominal fat into the area of the mesh in a pannus-like fashion.The pattern here suggests dehiscence of the mesh attachment.¿ during the procedure, the old mesh as well as the hernia sac were excised as alleged a bard/davol 4.3x5.5¿ ventrio (device #2) was implanted.On or about (b)(6) 2016:the patient underwent surgery to explant the failed mesh device.During the procedure, the doctor noted ¿it was readily found that the previously placed onlay mesh was completely unincorporated.¿ as reported, patient continues to experience complications related to the bard/davol kugel patch (device #1) and the bard/davol ventrio (device #2).She has already and will likely require additional surgeries to repair the damage from the product.The bard/davol kugel patch (device #1) and the bard/davol ventrio(device #2) implanted in patient failed to reasonably perform as intended.The product caused serious injury and had to be surgically removed via invasive surgery, necessitating additional invasive surgery to repair the hernia that the product had initially been implanted to treat.The patient has been injured and sustained past and future, severe and permanent pain, suffering, anxiety, depression, disability, impairment due to the alleged defective bard/davol kugel patch(device #1) and ventrio (device #2).

• Brand Name: KUGEL PATCH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8037142
• Report Number: 1213643-2018-03842
• Device Sequence Number: 1435628
• Product Code: FTL
• UDI-Device Identifier: 00801741016356
• UDI-Public: (01)00801741016356
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K963141
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2018

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: 03/28/2019
• Device Catalogue Number: 0010103
• Device Lot Number: HUYA0755
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2018
• Initial Report FDA Received Date: 11/05/2018
• 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; Disability