MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO; SURGICAL MESH

Catalog Number	5955790
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Hernia (2240)
Date of Event	08/15/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including disability, hernia recurrence, infection, abscess and subsequent surgical intervention for mesh removal.The instructions-for-use (ifu) supplied with the device lists hernia recurrence, infection, adhesions, inflammation as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.In regard to the infection, the warnings section of the ifu states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection may require removal of the prosthesis." this emdr represents the bard/davol ventralight st w/ echo (device #2).An additional emdr was submitted to represent the bard/davol ventralight st mesh (device #1).Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that on or about (b)(6) 2009, the patient was implanted with a non-bard/davol product to repair an umbilical hernia.It is reported that on or about (b)(6)2011, the patient underwent revision of the non-bard/davol product and was implanted with a bard/davol ventralight st mesh to repair an umbilical hernia.It is alleged that on or about (b)(6) 2012, the patient underwent an umbilical hernia repair and a bard/davol ventralight st mesh w/echo ps was implanted.It is alleged that the patient underwent partial removal of the mesh products on or about (b)(6) 2012, (b)(6) 2015, (b)(6) 2015 and (b)(6)2016.It is alleged that the patient experienced and/or continues to experience severe and chronic pain/discomfort, inflammation, dense adhesions, adhesions to the bowel and mesh, recurrence, infection, open draining wound, abscess, bowel issues/complications, and multiple revision/removal surgeries.Attorney alleges that the st bard mesh implanted in the patient failed to reasonably perform as intended, caused serious injury and had to be surgically removed via invasive surgery, and necessitated additional invasive surgery to repair the hernia that the st bard mesh was initially implanted to treat.It is alleged that the patient is at a higher risk of severe complications during an abdominal surgery, to the extent that future abdominal operations might not be feasible.Attorney alleges past, present, and future damages, that the patient has been injured, sustained severe and permanent pain, suffering, disability, impairment, mental anguish and emotional distress.It is also alleged that the device was defective.

• Brand Name: VENTRALIGHT ST W/ ECHO
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 12661674
• Report Number: 1213643-2021-08195
• Device Sequence Number: 1309193
• Product Code: FTL
• UDI-Device Identifier: 00801741031762
• UDI-Public: (01)00801741031762
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K122436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 10/19/2021

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: 11/28/2012
• Device Catalogue Number: 5955790
• Device Lot Number: HUVK1371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/19/2021
• 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