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

Catalog Number	0123114
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Injury (2348); Disability (2371)
Date of Event	07/26/2006
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) 2006.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.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 5months post implant of composix e/x mesh, patient was diagnosed with infection and pain thereby underwent repair with removal of mesh.The warning section of the ifu states, " if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the prosthesis.An unresolved infection may require removal of the prosthesis." 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) 2006.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) 2006 - patient was diagnosed with incisional hernia thereby underwent laparoscopic repair with the implant of composix e/x mesh.Per operative notes, ¿large colostomy site hernia sac, small bowel and colon were dissected.A composix e/x mesh was placed and secure it with suture.¿ (b)(6) 2006 - patient was diagnosed with removal of infected mesh and repair of complex incisional hernia thereby underwent open repair with the explant of composix e/x mesh and implant of biological mesh.Per operative notes, ¿infected mesh was removed.Biological mesh was placed and secure it with suture.¿ attorney alleges that patient had abscesses, infections and pain.

• Brand Name: COMPOSIX MESH E/X
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: 10512787
• Report Number: 1213643-2020-08134
• Device Sequence Number: 19531364
• Product Code: FTL
• UDI-Device Identifier: 00801741031175
• UDI-Public: (01)00801741031175(10)43COD303
• 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: 2006
• Device Explanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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: 0123114
• Device Lot Number: 43COD303
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 04/25/2025
• 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: 64 YR
• Patient Sex: Female