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

Catalog Number	0123680
Medical Device Problem Codes	Material Deformation (2976); Migration (4003)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Hernia (2240)
Date of Event	06/04/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2011 - patient was diagnosed with recurrent incisional abdominal hernia thereby underwent open repair with the implant of composix e/x meshes (device 1, 2).Per op notes, "a large hernia sac was noted fascial rent in midline.Two composix meshes were used on each side of defect due to large rent.The first composix e/x mesh (device 1) was placed as sublay on left side of defect and another composix e/x mesh (device 2) was placed on right side of defect using sutures." on (b)(6) 2013 - patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair.Per op notes, "the adhesions were freed up.The hernia sac and contents were removed.The defect was noted.The previously placed mesh (device 1, 2) had collapsed and avulsed into some of hernia sac, colon, liver.A mesh was placed to overlap the hernia defect into abdominal cavity using tacks." note: the mesh implanted in this procedure will be considered as 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.Note, the manufacturing date (15-feb-2011) is considered to be a best estimate.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 ; 8005566756
• MDR Report Key: 25551991
• Report Number: 1213643-2026-00773
• Device Sequence Number: 5547186
• Product Code: FTL
• UDI-Device Identifier: 00801741031199
• UDI-Public: (01)00801741031199(17)160328(10)HUVB1389
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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 Expiration Date: 03/28/2016
• Device Catalogue Number: 0123680
• Device Lot Number: HUVB1389
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2011
• 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