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

Catalog Number	0134790
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930); Hernia (2240)
Date of Event	09/16/2013
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, wound dehiscence and infection.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.In regards 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 mesh.An unresolved infection may require removal of the mesh." should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient was implanted with a bard/davol composix l/p mesh in the course of an incisional hernia repair surgery on (b)(6) 2013.It is alleged that further to the implantation with the product, the patient suffered mesh infection.Attorney alleges that the patient underwent a corrective revision surgery on (b)(6) 2013 and another corrective revision surgery on (b)(6) 2017.It is alleged that the patient has suffered injuries, losses, and damages resulting from numerous defects in the product that create an unreasonably high risk of injury with severe permanent adverse health consequences.It is also alleged that the patient sustained injuries including infection, adhesion, wound dehiscence, evisceration, hernia recurrence, permanent injuries including scarring, disfigurement, suffering and physical disability.It is alleged that the patient continues to undergo medical care and treatment.It is also alleged the device was defective.

• Brand Name: MESH COMPOSIX L/P
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 12457829
• Report Number: 1213643-2021-07496
• Device Sequence Number: 5156421
• Product Code: FTL
• UDI-Device Identifier: 00801741031304
• UDI-Public: (01)00801741031304
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K061754
• 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): 09/12/2021

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: 06/28/2016
• Device Catalogue Number: 0134790
• Device Lot Number: HUVF0490
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 09/12/2021
• 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