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	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Staphylococcus Aureus (2058)
Date of Event	02/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
With the current information provided, no conclusion can be made.It is alleged the patient experienced infection and adhesions.Adhesions is a known inherent risk of hernia repair surgery and are identified in the adverse reactions section of the ifu as a known possible complication.In regards to infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ with no lot number provided a review of the manufacturing records could not be conducted.This file represents one of the two (2) composix lp devices, a second file was created to address the second composix lp device.No device returned for evaluation.
Event or Problem Description
As reported, on (b)(6) 2007, the patient underwent surgery for implant of two (2) bard/davol composix l/p mesh.It was reported that the patient began to experience abdominal pain toward the end of 2018 and underwent additional surgery on (b)(6) 2019 for partial explant of both devices.It is alleged that the mesh had caused a (b)(6) infection and lysis of adhesions from her appendix and intestines.
Event or Problem Description
As reported, on (b)(6) 2007, the patient underwent surgery for implant of two (2) bard/davol composix l/p mesh.It was reported that the patient began to experience abdominal pain toward the end of 2018 and underwent additional surgery on (b)(6) 2019 for partial explant of both devices.It is alleged that the mesh had caused a staph infection and lysis of adhesions from her appendix and intestines.Addendum per additional information provided: (b)(6) 2007 ¿ patient was diagnosed with large incisional hernia thereby underwent laparoscopic repair with implant of composix l/p mesh (device 1 ¿ left) and (device 2 - right).Per operative notes, ¿adhesions were lysed.A large composix l/p mesh (device 1-left) was placed in the mid abdomen extending to the left side, another overlying a smaller composix l/p mesh (device 2-right) was placed to the right side and tacked.¿ (b)(6) 2019 ¿ patient was diagnosed with right lower quadrant abscess, fistula, left inguinal hernia infected mesh thereby underwent laparoscopic repair with removal of (device 2-right) and an implant of ventralex mesh (device 3).Per operative notes, ¿adhesions were lysed.The suprapubic left side hernia was seen.A ventralex mesh (device 3) was placed anchored to the tissue.In the right lower quadrant abscess cecum was attached to the mesh was infected purulent material was present along with the pieces of mesh (device 2) that were not incorporated were removed.¿ (note: there is no product identifier given for implanted ventralex mesh in this procedure).
Additional Manufacturer Narrative
With the current information provided, no conclusion can be made.It is alleged the patient experienced infection and adhesions.Adhesions is a known inherent risk of hernia repair surgery and are identified in the adverse reactions section of the ifu as a known possible complication.In regards to infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ with no lot number provided a review of the manufacturing records could not be conducted.This file represents one of the two (2) composix lp devices, a second file was created to address the second composix lp device.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the udi.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.

• 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: 9694872
• Report Number: 1213643-2020-01101
• Device Sequence Number: 2362056
• Product Code: FTL
• UDI-Device Identifier: 00801741031274
• UDI-Public: (01)00801741031274(10)DAQJ0027
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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: 0134460
• Device Lot Number: DAQJ0027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 10/15/2025
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 55 KG