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

Catalog Number	0112680
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	01/27/2009
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 mdr represents the bard flat mesh (device 4).Additional supplemental emdrs were submitted to represent the composix l/p mesh (device 2) and composix kugel patch (device 3).An additional emdr was created in gcs to represent bard flat 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: on (b)(6) 2007 - patient was diagnosed with midline incisional hernia thereby underwent open repair with implant of bard flat mesh (device 1).Per operative notes, ¿an elliptical incision was made around the previous skin incision.The hernia sac was dissected out.A bard flat mesh (device 1) was placed into the defect and closed with sutures.¿ on (b)(6) 2007 - patient was diagnosed with recurrent ventral hernia, thereby underwent open repair with implant of composix l/p mesh (device 2).Per operative notes, ¿a midline incision was made through previous skin incision site.The hernia sac was dissected out.Previously placed (device 1) that was present and it was in good condition.A composix l/p mesh (device 2) was placed into the peritoneal space and secure it with sutures.¿ on (b)(6) 2008 ¿ patient was diagnosed with recurrent ventral hernia, and right lower quadrant hernia, scar tissue, adhesion, pain thereby underwent laparoscopic repair with implant of composix kugel patch (device 3) and bard flat mesh (device 4).Per operative notes, ¿an incision was made into the midline from the xiphoid.The previously placed meshes (device 1 and device 2) were present in that area.All bowel adhesions were taken down sharply.All hernia sacs were dissected out.A composix kugel was placed into the ventral region.A bard flat mesh (device 4) was placed into the right lower quadrant.This was done in a way to grasp the edge of the (device 4) and placed the (device 3) against the fascia that was going to be sewn over it with sutures.¿ on (b)(6) 2009 - patient was diagnosed with erosion of previous mesh, abdominal pain, thereby underwent open repair with explant of bard flat mesh (device 1), composix l/p mesh (device 2) and composix kugel patch (device 3) and bard flat mesh (device 4) and implant of biological graft.Per operative notes, ¿an incision was made that extended from the xiphoid to the umbilicus.Previously placed (device 1,2,3,4) were excised entirely.A biological graft was placed into the defect and closed the defect with 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: 25110834
• Report Number: 1213643-2026-00600
• Device Sequence Number: 10249356
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530(10)43FND130
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K251557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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: 43FND130
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/07/2026
• 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: 50 YR
• Patient Sex: Male