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

Catalog Number	0123790
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol composix e/x (device #1) used to treat the patient.The patient's attorney did allege surgical intervention; however, no details have been provided.No lot number has been provided therefore a review of the manufacturing records is not possible.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol composix e/x (device #1).An additional emdr was submitted to represent the bard/davol ventrio (device #2).
Event or Problem Description
Attorney alleges that on (b)(6) 2016 or (b)(6) 2018, the patient underwent surgery for implant of an unspecified bard/davol composix e/x (device #1) or an unspecified bard/davol ventrio patch (device #2).It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the patient is making a claim for an adverse patient outcome against the composix e/x (device #1) and ventrio patch (device #2).As reported, the attorney alleges product is defective and that the patient experienced emotional distress.
Additional Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol composix e/x (device #1) used to treat the patient.The patient's attorney did allege 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-mar-2017) is considered to be a best estimate.This supplemental emdr represents the bard/davol composix e/x (device #1).An additional emdr was submitted to represent the bard/davol ventrio (device #2).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.
Event or Problem Description
Attorney alleges that on (b)(6) 2016 or (b)(6) 2018, the patient underwent surgery for implant of an unspecified bard/davol composix e/x (device #1) or an unspecified bard/davol ventrio patch (device #2).It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the patient is making a claim for an adverse patient outcome against the composix e/x (device #1) and ventrio patch (device #2).As reported, the attorney alleges product is defective and that the patient experienced emotional distress.Addendum per additional information provided: (b)(6) 2016 ¿ patient was diagnosed with spigelian hernia thereby underwent open repair with implant of ventrio hernia patch (device 1).Per operative notes, ¿ in the left lower quadrant, below the umbilicus the hernia with sac was encountered.A small hernia with sac was reduced and ventrio hernia patch (device 1) was placed over the defect and secured in place circumferentially with sutures.¿ (b)(6) 2018 ¿ patient was diagnosed with recurrent spigelian hernia, left groin direct hernia and abdominal pain thereby underwent open repair with removal of prior mesh (device 1) and implant of composix e/x mesh (device 2).Per operative notes, ¿ the recurrent spigelian hernia protruded below the prior mesh (device 1) in the left lower quadrant area was noted.The extensive intraabdominal adhesions to mesh (device 1) were lysed.The old mesh (device 1) wrinkled , folded and appeared inadequate to cover the defect was removed completely and composix e/x mesh (device 2) was placed over the hernia defect and anchored with sutures.The direct hernia in the left groin was reduced and closed primarily with sutures.¿.

• Brand Name: MESH - COMPOSIX E/X
• 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: 8473402
• Report Number: 1213643-2019-02539
• Device Sequence Number: 19312682
• Product Code: FTL
• UDI-Device Identifier: 00801741031205
• UDI-Public: (01)00801741031205(17)220328(10)HUBQ2144
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2025

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: 03/28/2022
• Device Catalogue Number: 0123790
• Device Lot Number: HUBQ2144
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 12/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2017
• 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 Sex: Female