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

Catalog Number	0112660
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Scar Tissue (2060); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	08/04/2014
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 mdr represents the bard flat mesh (device 1).An additional supplemental emdr was submitted to represent the composix e/x mesh (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) 2007 - patient was diagnosed with incarcerated ventral hernia thereby underwent open repair with implant of bard flat mesh (device 1).Per op notes, ¿a midline incision was made near the xiphoid, and the hernia was identified in the upper part of the abdomen.Multiple defects within the fascia was noted and the incarcerated omentum was freed up and resected.A bard flat mesh (device 1) was placed to the fascia and tacked with sutures.¿ on (b)(6) 2011 - patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with implant of synthetic mesh.Per op notes, ¿incision was made on the left upper quadrant.Adhesions noted along the abdominal wall were taken down.Several loops of small bowel toward the right side of abdomen were taken down.Bowel stuck to the abdominal wall was taken down.The old mesh was visualized from prior hernia repair.A synthetic mesh was placed through the left upper quadrant incision and secured with sutures.¿ on (b)(6) 2012 ¿ patient was diagnosed with small bowel obstruction with recurrent ventral hernia thereby underwent open repair with partial excision of synthetic mesh and implant of biological mesh.Per op notes, ¿a midline incision was made over old scar and identified the fascial defect to the right of the synthetic mesh.Synthetic mesh was partially excised on the left and right side, and the well incorporated mesh was left.Adhesions were lysed and adhesive band wrapped around the bowel wall was excised.Large fascial defect was repaired by component separation on the right side.A biological mesh was placed subfascial and sutured.¿ on (b)(6) 2014 - patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic converted to open repair with implant of composix e/x mesh (device 2) with partial excision of bard flat mesh (device 1).Per op notes, ¿a left upper quadrant incision was made.Adhesions and small bowel loops stuck to the abdominal wall were taken down.The hernia with two fascial defects was identified on the left and right of the umbilicus region.Some of the old mesh (device 1) was excised and well incorporated mesh was left in place.The fascial defect in the left side of the abdomen was repaired with sutures and right-side facial defect was mobilized.A composix e/x mesh (device 2) was placed and secured with sutures.¿ on (b)(6) 2017 ¿ patient was diagnosed with infected abdominal wall mesh thereby underwent open repair with implant of biological mesh and excision of bard flat mesh (device 1) and composix e/x mesh (device 2).Per op notes, ¿a drainage sinus on the left side of the abdomen with some purulent fluid was identified and erythema was noted.A midline incision was made over old scar and a lot of scar tissue along the abdominal wall was noted.Dissection was made around the mesh (device 1 and 2) and identified the transverse colon had eroded through the mesh.The bard flat mesh (device 1) and composix e/x mesh (device 2) was removed from the abdominal wall.Small bowel adhered to the underside of the mesh was taken down.Two fascial defects were noted and a biological mesh was placed and sutured.Colectomy and incision and drainage of abdominal wall abscess was performed.¿.

• 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: 24256326
• Report Number: 1213643-2026-00077
• Device Sequence Number: 9971058
• Product Code: FTL
• UDI-Device Identifier: 00801741016516
• UDI-Public: (01)00801741016516(10)43AQD022
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2026

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: 0112660
• Device Lot Number: 43AQD022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/04/2026
• 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: 49 YR
• Patient Sex: Male