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

Catalog Number	0112980
Medical Device Problem Codes	Defective Device (2588); Material Deformation (2976); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Seroma (2069); Hernia (2240)
Date of Event	03/06/2017
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, seroma, chronic pain and subsequent surgical intervention for mesh removal.The instructions-for-use supplied with the device lists hernia recurrence, adhesions, inflammation and seroma as possible complications.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This emdr represents the bard/davol perfix plug (device #1).Additional emdrs were submitted to represent the perfix plug(device #2) and the bard/davol perfix plug (device #3).Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
Attorney alleges that the patient was implanted with the bard/davol perfix plug and non-bard/davol mesh, collectively known as "mesh products".Attorney alleges that the patient was implanted with a non-bard/davol mesh to repair a hernia in the right lower quadrant on or about (b)(6) 2012.It is alleged that as a direct and proximate result of defendants¿ defective design, manufacture, marketing, distribution, and/or sale of non-bard/davol mesh and the perfix plugs and placing the defective products into the stream of commerce, the patient has been injured and damaged as follows: it is alleged that on (b)(6) 2013, the patient underwent revision of the non-bard/davol mesh.It is alleged that on or about (b)(6) 2013, the patient underwent revision of the non-bard/davol mesh, underwent right abdominal hernia repair and was implanted with two bard/davol perfix plugs.It is also alleged that on or about on or about (b)(6) 2017, the patient underwent removal of the mesh products, right lower quadrant hernia repair and was implanted with a third bard/davol perfix plug.It is alleged that the patient underwent revision of the perfix plug on or about (b)(6) 2018 and on or about (b)(6) 2019.It is alleged that on or about (b)(6) 2019, the patient underwent removal of the bard/davol perfix plug.It is alleged that the patient experienced and/or continues to experience severe and chronic pain/discomfort, inflammation, dense adhesions, mesh contraction, seroma, recurrence, and surgeries to remove the mesh products, which have impaired the activities of daily living.It is also alleged that the patient underwent additional surgeries on or about (b)(6) 2019 and (b)(6) 2020.It is alleged that the patient at a higher risk of severe complications during abdominal surgery, to the extent that future abdominal operations might not be feasible.It is alleged that the patient has suffered and will continue to suffer physical pain and suffering, as well as mental anguish and emotional distress.It is alleged that when the mesh products were implanted in the patient's body it was defectively manufactured.Attorney also alleges past, present, and future damages, including but not limited to, pain and suffering for severe and permanent personal injuries sustained by the patient and permanent impairment.

• Brand Name: PERFIX PLUG
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED 3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 14738536
• Report Number: 1213643-2022-94796
• Device Sequence Number: 2226929
• Product Code: FTL
• UDI-Device Identifier: 00801741016684
• UDI-Public: (01)00801741016684
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2022

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: 02/28/2018
• Device Catalogue Number: 0112980
• Device Lot Number: HUXB0134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Sex: Female