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

Catalog Number	0112680
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	09/29/2014
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 flat mesh (device 4).Additional supplemental emdr and emdrs were submitted to represent the bard flat mesh (device 1) and bard flat mesh (device 2 & 3).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) 2001 - patient was diagnosed with abdominal wall incisional hernia thereby underwent open repair with implant of two bard flat meshes (device 1 and 2).Per operative notes, "in the lower midline in upper portion of prior c-section wound, an incisional hernia with sac was dissected out of the subcutaneous tissue down to the fascial ring.A small hernia in the peritoneal space near the level of umbilicus was noted.Both hernias were communicated and made into a single hernia.The peritoneum was closed with sutures, and a piece of bard flat mesh (device 1) was placed above the level of the peritoneum and sutured peripherally.A second piece of bard flat mesh (device 2) was placed over the top of the fascia and secured with sutures.The wound was irrigated and reapproximated with sutures." on (b)(6) 2002 - patient was diagnosed with recurrent umbilical and incisional hernia thereby underwent repair with implant of two bard flat meshes (device 3 and 4).(note: there is no operative notes provided for this procedure in medical records).On (b)(6) 2014 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent laparoscopic repair with implant of sepramesh ip (device 5).Per operative notes, "the contents of hernia containing viscera were reduced.The hernia defect was closed primarily with sutures over the hernia and a piece of sepramesh ip (device 5) was placed as an overlap on all sides of the defect and sutured on each edge.The mesh (device 5) was tacked circumferentially, and fascia was closed using sutures.".

• Brand Name: BARD 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: 24938600
• Report Number: 1213643-2026-00529
• Device Sequence Number: 17482014
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530(10)43CLD198
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K251557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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 Catalogue Number: 0112680
• Device Lot Number: 43CLD198
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 04/21/2026
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 108 KG