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

Catalog Number	5959480
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	05/19/2015
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 disability, hernia recurrence, scarring, disfigurement, chronic pain and revision surgery.The instructions-for-use supplied with the device lists hernia recurrence as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This mdr represents the bard/davol sepramesh ip (device #1).An additional mdr was submitted to represent the bard flat mesh (device #2).Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges: the patient was implanted with bard/davol sepramesh ip and bard mesh (bard flat mesh) (the "product").The patient was implanted with bard/davol sepramesh ip on (b)(6) 2015 in the course of an incisional hernia repair surgery.It is alleged that the patient suffered the development of mesh failure, hernia recurrence and chronic pain.It is also alleged that on or about (b)(6) 2015, the patient underwent corrective revision surgery and on or about (b)(6) 2016, the patient underwent another corrective revision surgery.It is alleged that on (b)(6) 2019, the patient underwent another corrective revision surgery with bard mesh (bard flat mesh).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 the plaintiff suffered permanent injuries including scarring, disfigurement.Attorney also alleges that the plaintiff suffering, psychological and emotional injuries and permanent physical disability.It is alleged that the plaintiff continues to undergo medical care and treatment.It is also alleged that the patient sustained personal injury, emotional distress and the device was defective.

• Brand Name: SEPRAMESH IP
• 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: 15813927
• Report Number: 1213643-2022-00746
• Device Sequence Number: 12094430
• Product Code: FTL
• UDI-Device Identifier: 00801741031816
• UDI-Public: (01)00801741031816
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2022

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: 10/28/2016
• Device Catalogue Number: 5959480
• Device Lot Number: HUYJ1598
• 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
• Date Device Manufactured: 11/29/2014
• 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