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

Catalog Number	0123460
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422); Wrinkling (2613); Fibrosis (3167)
Date of Event	04/03/2018
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.Note, the manufacturing date (15-oct-2010) is considered to be a best estimate.This mdr 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.
Event or Problem Description
Per information provided: (b)(6) 2010 - patient was diagnosed with recurrent incisional hernia with pain thereby underwent laparoscopic repair with implant of composix e/x mesh (device 1).Per operative notes, ¿multiple anterior abdominal wall adhesions with a large, herniated defect in from prior pfannenstiel incision was noted.The adhesions were taken down, and large defect was reduced and composix e/x mesh (device 1) was placed and over the defect in the right lower quadrant and tacked in place.The fascia was closed and secured with sutures and tacks.¿ (b)(6) 2011 ¿ patient had recurrent incisional hernia thereby underwent laparoscopic repair with implant of composix e/x mesh (device 2) and removal of tacks.(note: there is no operative note provided for this procedure in medical records).(b)(6) 2018 ¿ patient was diagnosed with recurrent incisional hernia, small bowel obstruction with abdominal pain thereby underwent open repair with removal of prior meshes (device 1 and 2) and primary repair of recurrent hernia.Per operative notes, ¿minor omental adhesions were taken down and wrinkled meshes (device 1 and 2) in lower abdomen in midline was noted.The dilated bowel and decompressed terminal ileal segment with infolding was removed.The dense fibrosis around the meshes (device 1 and 2) was encountered, the meshes (device 1 and 2) with fibrotic tissues were removed entirely and mesenteric defect was closed and primarily sutured circumferentially.¿.

• 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: 24444449
• Report Number: 1213643-2026-00216
• Device Sequence Number: 10373290
• Product Code: FTL
• UDI-Device Identifier: 00801741031182
• UDI-Public: (01)00801741031182(17)151128(10)HUUJ0464
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K002684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2026

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: 11/28/2015
• Device Catalogue Number: 0123460
• Device Lot Number: HUUJ0464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2010
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 72 KG