MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 MESH - COMPOSIX L/P; SURGICAL MESH

Catalog Number	0134460
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240); Injury (2348)
Date of Event	03/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol composix l/p (device #1).An additional emdr was submitted to represent the bard/davol ventralex hernia patch (device #2).Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for the implant of unspecified bard/davol composix l/p and ventralex hernia patch on (b)(6) 2008 and/or (b)(6) 2008.As reported, the patient is making a claim for an adverse patient outcome against both devices.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: this supplemental emdr is submitted to document additional information provided.Root cause is inconclusive, no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-may-2008) is considered to be a best estimate.Updated fields: a2, b3, b4, b5, b7, d3, d4, d.6a (date of implant), d.6b (date of explant), g3, g6, h2, h4, h6, h10.This supplemental emdr represents the composix l/p mesh (device #2).An additional supplemental emdr was submitted to represent the bard/davol mesh -ventralex mesh (device #1).Note: section a through f - 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.H3 other text : not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for the implant of unspecified bard/davol composix l/p and ventralex hernia patch on (b)(6) 2008.As reported, the patient is making a claim for an adverse patient outcome against both devices.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2008 - patient was diagnosed with symptomatic enlarging umbilical hernia thereby underwent open repair with the implant of bard ventralex mesh (device #1).Per operative notes, ¿a bard ventralex mesh (device #1) was placed and sutured.¿ (b)(6) 2008 - patient was diagnosed with incarcerated recurrent ventral hernia, adhesion thereby underwent open repair implant of composix lp mesh (device #2).Per operative notes, ¿all adhesions were taken down.A composix lp mesh (device #2) was placed and sutured.¿ (b)(6) 2018 - patient was diagnosed with abdominal wall hernia, adhesion, scar tissue thereby underwent open repair with explant of composix lp mesh (device #2) and implant of the bard phasix flat mesh (device #3).Per operative notes, ¿scar tissues were dissected.A large hernia sac was dissected free from the abdominal wall.A composix lp mesh (device #2) was partially removed.One bard phasix flat mesh (device #3) was placed and sutured.¿.

• Brand Name: MESH - COMPOSIX L/P
• 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 ; 4018258495
• MDR Report Key: 9810579
• Report Number: 1213643-2020-02246
• Device Sequence Number: 14183455
• Product Code: FTL
• UDI-Device Identifier: 00801741031274
• UDI-Public: (01)00801741031274(17)130828(10)HUSE1340
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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: 08/28/2013
• Device Catalogue Number: 0134460
• Device Lot Number: HUSE1340
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2008
• 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
• Patient Age: 54 YR
• Patient Sex: Male