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

Catalog Number	0123810
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Hernia (2240); Injury (2348); Disability (2371); Obstruction/Occlusion (2422)
Date of Event	03/27/2009
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "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.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 an unspecified bard/davol composix e/x on (b)(6) 2005.As reported, the patient is making a claim for an adverse patient outcome against the composix e/x.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.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "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: 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: 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 the patient underwent surgery for implant of an unspecified bard/davol composix e/x on (b)(6) 2005.As reported, the patient is making a claim for an adverse patient outcome against the composix e/x.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: (b)(6) 2005 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of composix e/x.Per op notes, "a composix e/x was placed in the abdomen using prolene sutures." (b)(6) 2007 - patient was diagnosed with recurrent ventral hernia thereby underwent repair with the implant of synthetic mesh.Per op notes, "the previous mesh was noted, a synthetic mesh was placed." (b)(6) 2007 - patient was diagnosed with incarcerated ventral hernia anterior to synthetic graft.Per op notes, "noted hematoma to the synthetic mesh, another synthetic mesh was placed." (b)(6) 2008 - patient was diagnosed with small bowel obstruction due to adhesions thereby underwent repair with lysis of adhesions.Per op notes, "a midline incision was made above the umbilicus, there appeared to be a large amount of scar tissue.Noted synthetic mesh, adhesions were taken down." (b)(6) 2009 - patient was diagnosed with infection of abdominal wall mesh thereby underwent repair with partial removal of composix e/x mesh.Per op notes, "noted the composix e/x mesh and was removed partially." v2009 - patient was diagnosed with large recurrent incisional ventral hernia with infected mesh thereby underwent repair with removal of composix e/x mesh.Per op notes, "multiple abscesses were noted in the old mesh, hernia was looked like a composix e/x mesh and it was removed.A synthetic mesh was placed.".

• 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: 10604457
• Report Number: 1213643-2020-08897
• Device Sequence Number: 19568435
• Product Code: FTL
• UDI-Device Identifier: 00801741031212
• UDI-Public: (01)00801741031212(10)43BPD284
• 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: 2005
• Device Explanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2025

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 Catalogue Number: 0123810
• Device Lot Number: 43BPD284
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/27/2025
• 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: 45 YR
• Patient Sex: Male