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

Catalog Number	0112720
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	06/03/2011
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 #2).An additional supplemental emdr was submitted to represent the bard/davol mesh ¿ composix kugel (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) 2004 - patient was diagnosed with incarcerated recurrent ventral hernia thereby underwent open repair with the implant of composix kugel mesh (device #1).Per op notes, "identified the unknown marlex mesh.A composix kugel mesh (device #1) was placed into the abdominal wall using prolene sutures." (b)(6) 2004 - patient was diagnosed with seroma thereby underwent repair with debridement of seroma sinus, drainage of seroma and debridement with primary closure.(b)(6) 2005 - patient was diagnosed with abdominal wall abscess with infected mesh thereby underwent repair with removal of mesh (device #1) and lysis of adhesions.Per op notes, ¿the composix graft appeared as a hard mass.Dense adhesions were identified and the prior composix graft (device #1) was removed.Unknown marlex mesh was also excised.¿ (b)(6) 2007 - patient was diagnosed with recurrent incarcerated ventral hernia with small bowel obstruction thereby underwent open repair with the implant of bard flat mesh (device #2).Per op notes, ¿a bard flat mesh (device #2) was placed into the abdominal wall using prolene sutures.¿ (b)(6) 2011 - patient was diagnosed with recurrent small bowel obstructions, recurrent abdominal wall hernias thereby underwent open repair with the removal of mesh (device #2) and implant of bard flat mesh (device #3).Per op notes, ¿the mesh (device #2) was excised and a bard flat mesh (device #3) was placed.¿.

• 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: 22592870
• Report Number: 1213643-2025-00679
• Device Sequence Number: 21114352
• Product Code: FTL
• UDI-Device Identifier: 00801741016561
• UDI-Public: (01)00801741016561
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2025

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: 0112720
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 07/24/2025
• 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