MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. COMPOSIX MESH E/X; SURGICAL MESH

Catalog Number	0123790
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Necrosis (1971); Hernia (2240)
Date of Event	08/08/2019
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 permanent injury, hernia recurrence, adhesions and subsequent surgical intervention for mesh removal.The instructions-for-use (ifu) supplied with the device lists hernia recurrence and adhesions as possible complications.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.Not returned.
Event or Problem Description
Attorney alleges the patient underwent surgery to repair a midline hernia and implanted with a non-bard/davol product on or about (b)(6) 2012.It is alleged that the patient underwent revision surgery of the non-bard/davol product for a recurrent midline hernia and a bard/davol composix e/x was implanted on or about (b)(6) 2017.It is also alleged that the patient underwent removal surgery on or about (b)(6) 2019.Attorney alleges that the patient experienced and/or continues to experience severe and chronic pain/discomfort, dense adhesions, adhesions to the small intestine, mesh contraction, mesh was attached to a severe fibrotic plate, necrosis, fibrosis, recurrence, and surgery to remove mesh.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, including but not limited to, pain and suffering for severe and permanent personal injuries sustained by the patient.It is also alleged that the device was defective.

• Brand Name: COMPOSIX MESH E/X
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 12628139
• Report Number: 1213643-2021-08166
• Device Sequence Number: 11063997
• Product Code: FTL
• UDI-Device Identifier: 00801741031205
• UDI-Public: (01)00801741031205
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2021

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: 02/28/2021
• Device Catalogue Number: 0123790
• Device Lot Number: HUAP2569
• 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: 10/13/2021
• 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