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 Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Seroma (2069); Hernia (2240)
Date of Event	06/21/2013
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2009 ¿ patient was diagnosed with incarcerated incisional hernia with small bowel obstruction thereby underwent open repair with implant of bard flat mesh (device 1).Per operative notes, ¿the palpable hernia defect from previous umbilical hernia was noted.The chronic hernia with scarring fibrosis and adhesions to sac was reduced.The sacs were excised and bard flat mesh (device 1) was placed and secured with sutures circumferentially.¿ (b)(6) 2012 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of composix kugel mesh (device 2).Per operative notes, ¿ in the mid abdomen, a large recurrent hernia was dissected free from surrounding tissues and composix kugel mesh (device 2) was placed in the abdominal wall defect and sewn in place.The fascia was closed and secured with sutures.¿ (b)(6) 2012 - patient was diagnosed with seroma of abdominal wall and abdominal pain thereby underwent open repair with aspiration of abdominal wall seroma.Per operative notes, ¿the seroma fluid appeared clear and aspirated.The wound was irrigated and fascia was closed.¿ (b)(6) 2013 - patient was diagnosed with recurrent ventral/incisional hernia thereby underwent open repair with partial removal of prior meshes (device 1 and 2) and implant of composix kugel mesh (device 3).Per operative notes, ¿in the mid abdomen, a recurrent ventral/incisional hernia with previous mesh (device 1 and 2) was noted and dissected free from the surrounding tissues and removed.The small intestine was seen adherent to the prior meshes (device 1 and 2) were reduced.The fascia was reapproximated with sutures and composix kugel mesh (device 3) was placed into the abdominal wall and sewn in place with sutures.¿ (b)(6) 2018 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair with removal of old meshes (device 1, 2 and 3) and implant of synthetic mesh.Per operative notes, ¿dense adhesions were reduced and large recurrent hernia with sac was reduced and fascia was closed with sutures.A synthetic mesh was placed over the defect and secured with sutures.All the old meshes (device 1, 2 and 3) with seroma were removed and sutured.¿.
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.Note, the manufacturing date (15-sep-2007) is considered to be a best estimate.This mdr represents the bard flat mesh (device 1).An additional supplemental mdr was submitted to represent the composix kugel (device 2) and composix kugel (device 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.

• 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: 24018542
• Report Number: 1213643-2026-00012
• Device Sequence Number: 16088386
• Product Code: FTL
• UDI-Device Identifier: 00801741016561
• UDI-Public: (01)00801741016561(17)121128(10)HURI1128
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K251557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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 Expiration Date: 11/28/2012
• Device Catalogue Number: 0112720
• Device Lot Number: HURI1128
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2007
• 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: 59 YR
• Patient Sex: Male