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

Catalog Number	0117080
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	05/05/2015
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 permanent injury, hernia recurrence, bowel obstruction and subsequent surgical intervention.The instructions-for-use(ifu) supplied with the device lists hernia recurrence, pain and inflammation 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.
Event or Problem Description
Attorney alleges that the patient was implanted with a bard/davol perfix plug light.It is alleged that on (b)(6) 2013, the patient was implanted with the product in the course of an inguinal hernia repair surgery.It is alleged that further to the implantation of the product, the patient suffered the development of chronic pain, inflammation, swelling, bowel obstruction, gastrointestinal malfunction and hernia recurrence, necessitating further reparative surgery which occurred on (b)(6) 2015.Subsequent to the latter surgery, the patient has continued to suffer from chronic pain, inflammation, swelling, bowel obstructions, gastrointestinal malfunction and hernia recurrence.It is alleged that the patient had suffered injuries, losses and damages resulting from numerous defects in the product that create unreasonably high risk of injury with severe permanent adverse health consequences.It is alleged that the patient to experience severe pain and suffering, including chronic pain.It is alleged that the patient has been treated with a course of hospitalization, diagnostic imaging, revision surgery, serum testing, antibiotics, analgesics, and rest.It is also alleged that the patient will require further invasive repair surgery, physiotherapy, rehabilitation and will continue to require other medical care.It is also alleged that the device was defective.

• Brand Name: PERFIX PLUG LIGHT
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 12730374
• Report Number: 1213643-2021-08409
• Device Sequence Number: 13822964
• Product Code: FTL
• UDI-Device Identifier: 00801741030970
• UDI-Public: (01)00801741030970
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2021

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: 03/28/2018
• Device Catalogue Number: 0117080
• Device Lot Number: HUXC0185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 11/01/2021
• 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: Hospitalization; Required Intervention; Disability
• Patient Age: 45 YR