MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 FLAT MESH; SURGICAL MESH

Catalog Number	0112720
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446)
Date of Event	03/02/2012
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-2011) is considered to be a best estimate.This mdr represents the bard flat mesh (device 3).An additional supplemental emdr was submitted to represent the bard soft mesh (device 1).An additional supplemental emdr was submitted to represent the composix kugel patch (device 2).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) 2011 - patient was diagnosed with incisional abdominal wall hernia thereby underwent open repair with implant of bard soft mesh (device 1).Per operative notes, ¿an infraumbilical midline incision was made through subcutaneous tissue.The hernia sac was excised entirely.A bard soft mesh (device 1) was placed into the defect and closed with sutures.¿ on (b)(6) 2012 ¿ patient was diagnosed with complex left abdominal wall and recurrent incisional abdominal wall hernia, adhesion thereby underwent open repair with implant of composix kugel patch (device 2) and bard flat mesh (device 3).Per operative notes, ¿an incision was carefully dissected down through the subcutaneous tissue into the midline.The recurrent incisional abdominal wall hernia sac was dissected out.There were some dense adhesions which were dissected out.A composix kugel patch (device 2) was placed into the midline of abdomen.An incision was made into the left anterior abdominal wall.The hernia sac was dissected out.A bard flat mesh (device 3) was placed into the left abdominal wall and secure it with sutures.¿ on (b)(6) 2012 - patient was diagnosed with left abdominal wound infection with infected mesh, seroma, abscess thereby underwent open repair with explant of bard flat mesh (device 3).Per operative notes, ¿an incision was made in the left side of abdomen.The hernia sac was excised entirely.There were some serosal fluid into the abdomen which were drained entirely.Dense abscess was identified which was drained.Previously placed infected bard flat mesh (device 3) was fully excised from abdomen.The defect was closed with sutures.¿ on (b)(6) 2012 - patient was diagnosed with recurrent abdominal wall hernia, infected mesh, surgical wound infection, abscess, thereby underwent open repair with explant of bard soft mesh (device 1) and composix kugel patch (device 2).Per operative notes, ¿an incision was made through previous scar.The hernia sac was dissected out.There was large abscess cavity which was removed.Previously placed infected bard soft mesh (device 1) and composix kugel patch (device 2) were fully excised from abdominal cavity.The wound was irrigated.Vac placement was done.The hernia defect was closed with sutures primarily.¿.

• Brand Name: FLAT MESH
• 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: 24703316
• Report Number: 1213643-2026-00389
• Device Sequence Number: 21376368
• Product Code: FTL
• UDI-Device Identifier: 00801741016561
• UDI-Public: (01)00801741016561(17)161028(10)HUVJ0716
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

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: 10/28/2016
• Device Catalogue Number: 0112720
• Device Lot Number: HUVJ0716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2011
• 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: 54 YR
• Patient Sex: Female