MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Mesh - Composix E/X; Surgical Mesh

Catalog Number	0123113
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	03/10/2004
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: 26-nov-2001 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the implant of composix mesh (device 1).Per op notes, "the underlying hernia defect was dissected free.A piece of composix mesh (device 1) was placed into defect and secured to fascia using sutures." 11-apr-2002 - patient was diagnosed with recurrent ventral hernia, adhesion thereby underwent laparoscopic repair with the implant of composix e/x mesh.Per op notes, "there were massive adhesions up into the old hernia area and stuck to previously placed mesh.The defect was noted.An composix e/x mesh was placed as marlex portion up against the abdominal wall and secured circumferentially using tacks." 10-mar-2004 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair.Per op notes, "an infraumbilical cutdown was made in the middle where the hernia was noted.There were some adhesions.A mesh was sutured peripherally." (note: the mesh implanted in this procedure was unknown).
Additional Manufacturer Narrative
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.This emdr represents the composix e/x mesh (device 2).An additional supplemental emdr was submitted to represent the composix e/x 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 ; +1(800)556-6756
• MDR Report Key: 50089799
• Report Number: 1213643-2026-00988
• Device Sequence Number: 21452419
• Product Code: FTL
• UDI-Device Identifier: 00801741031168
• UDI-Public: (01)00801741031168(10)41FLDP08
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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
• Device Lot Number: 41FLDP08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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