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

Catalog Number	0123680
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	11/29/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2007: patient was diagnosed with incisional hernia thereby underwent open repair with the ventralex mesh (device #1).Per operative notes, "the hernia sac was identified, the hernia herniated omentum was dissected.The bridge between two hernias were incised.A ventralex mesh (device #1) was placed and sutured" (b)(6) 2009: patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the removal of mesh (device #1).Per operative notes, "the hernia sac was identified and excised.The omentum was adherent to the mass was reduced.The folded mesh (device #1) was removed.The small defect inferior to the recurrent hernia was repaired using sutures." (b)(6) 2009: patient was diagnosed with complex recurrent incisional hernia x2 and large abdominal wall hernia thereby underwent laparoscopic repair with the implant of composix e/x mesh (device #2).Per operative notes, "complex large abdominal wall hernia at the site of umbilicus was noted, another one inferior to this.A composix e/x mesh (device #2) was placed and tacked." (b)(6) 2011: patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of synthetic mesh.Per operative notes, "the hernia sac was opened and dissected away.A piece of synthetic mesh was placed and sutured." (note: there was no mention/visualization of the previously placed composix e/x mesh (device #2) during this procedure).
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.Note, the manufacturing date (15-nov-2008) is considered to be a best estimate.This emdr was submitted to represent the composix mesh e/x (device #2).An additional supplemental emdr submitted to represent the mesh: ventralex (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 ; 8005566756
• MDR Report Key: 22370502
• Report Number: 1213643-2025-00545
• Device Sequence Number: 14562125
• Product Code: FTL
• UDI-Device Identifier: 00801741031199
• UDI-Public: (01)00801741031199(17)131130(10)HUSK0924
• 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: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2025

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 Expiration Date: 11/30/2013
• Device Catalogue Number: 0123680
• Device Lot Number: HUSK0924
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2008
• 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: 51 YR
• Patient Sex: Female