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

Catalog Number	0123113
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	10/18/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges general allegations for past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient; 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 (device #2).An additional emdr was submitted to represent the bard/davol composix (device #1).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 implant of two unspecified bard/davol composite meshes (composix mesh) on (b)(6) 2008 and (b)(6) 2009.As reported, the patient is making a claim for an adverse patient outcome against both devices.Attorney alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of two unspecified bard/davol composite meshes (composix mesh) on (b)(6) 2009.As reported, the patient is making a claim for an adverse patient outcome against both devices.Attorney alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: on (b)(6) 2008 - patient was diagnosed with incarcerated incisional hernia thereby underwent open repair with the implant of composix mesh (device #1).Per op notes, "a composix mesh (device #1) was placed into the anterior abdominal wall using tacks." on (b)(6) 2009 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent laparoscopic repair with the implant of composix e/x mesh (device #2).Per op notes, "previous mesh appears to be intact.Lysis of adhesions was done.A composix e/x mesh (device #2) was placed into the abdomen using tacks." on (b)(6) 2011 - patient was diagnosed with recurrent incisional hernia thereby underwent repair with removal of mesh (device #1 & #2) and lysis of adhesions.Per op notes, "the previously placed mesh was retracted and attached to the upper edge of the fascial defect.Multiple bowel loops that were adherent to the mesh and the mesh was completely removed.A synthetic mesh was placed.".
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges general allegations for past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the brand name and 510k number.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.Corrected fields: d1 (brand name), g4 (510k number) this supplemental emdr represents the bard/davol composix e/x mesh (device #2).An additional supplemental emdr was submitted to represent the bard/davol composix 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.

• 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: 9785357
• Report Number: 1213643-2020-01989
• Device Sequence Number: 687832
• Product Code: FTL
• UDI-Device Identifier: 00801741031168
• UDI-Public: (01)00801741031168
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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 Catalogue Number: 0123113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 07/18/2025
• 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: Disability; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female