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

Catalog Number	0112680
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hernia (2240)
Date of Event	02/14/2007
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 2).An additional supplemental emdr was submitted to represent the bard flat mesh (device 1).An additional mdr was submitted to represent the kugel patch (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.
Event or Problem Description
Per information provided: (b)(6) 2005- patient was diagnosed with ventral incisional hernia, thereby underwent open repair with implant of bard flat mesh (device 1).Per op notes, ¿old midline scar was excised.The hernia sac was identified in the abdominal cavity and was dissected.A bard flat mesh (device 1) was cut and sutured to the anterior fascia¿.(b)(6) 2005- patient was diagnosed with ventral incisional hernia, thereby underwent open repair with implant of a bard flat mesh (device 2).Per op notes, ¿old scar was excised.The lateral portion of the closure was hernia which was then excised.A bard flat mesh (device 2) was placed over this repair and sutured.¿ (note: bard flat mesh (device 1) was not seen during this procedure) (b)(6) 2006- patient was diagnosed with umbilical hernia, thereby underwent open repair with implant of kugel patch.Per op notes, ¿a hernia sac was identified in the umbilical region and was dissected.A 3 x 4 inch piece of mesh (kugel patch) was cut and sutured to the anterior fascia with sutures¿.(b)(6) 2007- patient was diagnosed with recurrent ventral hernia, chronic abdominal pain, thereby underwent open repair with explant of bard flat mesh (device 1 and 2), kugel patch (device 3) with implant of synthetic mesh.Per op notes, ¿lower midline incision above the umbilicus, bard flat mesh (device 1 and 2), kugel patch (device 3) was entirely removed along with the meshoma.A synthetic mesh was then sutured under the left rectus sheath to cover stoma hernia¿.

• 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: 24376763
• Report Number: 1213643-2026-00158
• Device Sequence Number: 20252981
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530(10)43GPD062
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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: 43GPD062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/18/2026
• 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: 64 YR
• Patient Sex: Male