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

Catalog Number	0123810
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240)
Date of Event	06/26/2009
Type of Reportable Event	Serious Injury
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 bard mesh - composix e/x (device #2).An additional supplemental emdr was submitted to represent the bard mesh - composix e/x (device #1) and additional emdrs were submitted to represent bard mesh - composix e/x (device #3), bard mesh - composix kugel (device #4) and bard mesh - composix (device #5).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
Per information provided: on (b)(6) 2004 - patient was diagnosed with incarcerated recurrent incisional hernia thereby underwent laparoscopic repair with the explant of unknown marlex mesh and implant of three composix e/x mesh (device #1, device #2 and device #3).Per operative notes, ¿old unknown marlex mesh was removed.Three bard composix e/x mesh (device #1, device #2 and device #3) was placed and sutured.¿ (note: there was no information mentioned of the previously placed marlex mesh, lot and catalog no.Are unknown.) on (b)(6) 2009 - patient was diagnosed with incarcerated recurrent incisional hernia, pain, adhesion thereby underwent open repair with the implant of the bard composix kugel mesh (device #4).Per operative notes, ¿all adhesions were taken down.Bard composix kugel mesh (device #4) was placed and sutured.¿ on (b)(6) 2013 - patient was diagnosed with incarcerated ventral hernia, adhesion, pain thereby underwent open repair with explant of composix e/x mesh (device #1, device #2 and device #3) and bard composix kugel mesh (device #4) and implant of bard composix mesh (device #5).Per operative notes, ¿all adhesions were taken down.All old meshes composix e/x mesh (device #1, device #2 and device #3) and bard composix kugel mesh (device #4) were removed.One bard composix mesh (device #5) was placed and sutured.¿ on (b)(6) 2019 - patient was diagnosed with recurrent ventral hernia, mesh infection, adhesion thereby underwent open repair with explant of old bard composix mesh (device #5) and implant of bard ventralight st mesh (device #6).Per operative notes, ¿hernia sac, adhesions were taken down.Old bard composix mesh (device #5) was excised.One ventralight st mesh (device #6) was placed and sutured.¿.

• 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 ; 8005566756
• MDR Report Key: 22456023
• Report Number: 1213643-2025-00597
• Device Sequence Number: 12816574
• Product Code: FTL
• UDI-Device Identifier: 00801741031212
• UDI-Public: (01)00801741031212(10)43AND170
• 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: 2004
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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: 43AND170
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/09/2025
• 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 Age: 37 YR
• Patient Sex: Male