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 Codes	Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Impaired Healing (2378); Fibrosis (3167)
Date of Event	03/27/2006
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6)2005 - patient was diagnosed with large right inguinal hernia thereby underwent open repair with implant of composix kugel mesh (device 1), synthetic mesh and bard flat mesh (device 2).Per op notes, "a right transvers incision was made.The hernia was identified and reduced.The huge direct sac was returned to its subfascial position and the indirect sac was also dissected and freed.A large composix kugel mesh (device 1) was placed through the floor of the inguinal canal and secured to cooper¿s ligament.A second large synthetic mesh was placed through the internal ring and secured the wound subfascial portion onto the composix kugel mesh (device 1).A large piece of bard flat mesh (device 2) was placed on the entire floor of the inguinal canal and secured to the fascia at the pubic tubercle.The fascia was then closed with suture." (b)(6)2006 - patient was diagnosed with right scrotal hematoma thereby underwent open repair with incision and drainage of hematoma.Per op notes, "an incision was made in the upper scrotum.A large amount of serous fluid was removed and the wound was irrigated, removed some of the organized fibrous material.Drain was then placed in the cavity and secured with suture." (b)(6)2006 - patient was diagnosed with chronically infected right groin wound thereby underwent open repair with debridement of chronic wound.Per op notes, "a longitudinal incision was made along the upper portion of scrotum.A large portion of the hard, indurated tissue was then excised and the chronic cheesy material within was curetted.The wound was irrigated.".
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 composix kugel 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.

• 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 ; +1(800)556-6756
• MDR Report Key: 50949396
• Report Number: 1213643-2026-01270
• Device Sequence Number: 10348413
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: Preamendment
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 43GND517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 09/30/2026
• 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 Sex: Male