MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD SOFT MESH; SURGICAL MESH

Catalog Number	0117010
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Hernia (2240); Deformity/ Disfigurement (2360)
Date of Event	07/05/2010
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, chronic pain and revision surgery.The adverse reaction section of the instructions-for-use, supplied with the device lists hernia recurrence and pain as possible complications.Should additional information be provided, a supplemental mdr will be submitted.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Not returned.
Event or Problem Description
Attorney alleges that on (b)(6) 2010, the plaintiff was implanted with the bard soft mesh in the course of a left inguinal hernia repair surgery.Attorney alleges that further to the plaintiff implantation with the product, the plaintiff suffered the development of hernia recurrence, and chronic pain.Attorney alleges that on (b)(6) 2010, (b)(6) 2017 and (b)(6) 2018, the plaintiff underwent corrective revision surgeries.It is alleged that the plaintiff "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." attorney alleges that the plaintiff was left with permanent injuries including scarring, disfigurement, and chronic pain.It is alleged that the plaintiff continues to undergo medical care and treatment.It is also alleged that the device was defective.

• Brand Name: BARD SOFT MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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 ; 8005566756
• MDR Report Key: 15812848
• Report Number: 1213643-2022-00740
• Device Sequence Number: 12094419
• Product Code: FTL
• UDI-Device Identifier: 00801741030871
• UDI-Public: (01)00801741030871
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2022

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: 06/30/2014
• Device Catalogue Number: 0117010
• Device Lot Number: HUTE1198
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention; Disability
• Patient Sex: Male