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 Code	Hernia (2240)
Date of Event	04/22/2019
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.Note, the manufacturing date (15-apr-2015) is considered to be a best estimate.This mdr represents the bard flat mesh (device 2).An additional supplemental emdr was submitted to represent the bard flat 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.
Event or Problem Description
Per information provided: (b)(6) 2013- patient was diagnosed with epigastric hernia, thereby underwent open repair with implant of bard flat mesh (device 1).Per op notes, ¿the epigastric hernia was identified and dissected.A bard flat mesh (device 1) was placed and sutured to the peritoneal layer¿.(b)(6) 2015- patient was diagnosed with recurrent ventral hernia, thereby underwent laparoscopic repair with implant of synthetic mesh.Per op notes, ¿defect was noted on the right upper quadrant.A synthetic mesh was placed on the defect and tacked¿.(b)(6) 2015- patient was diagnosed with recurrent ventral incisional hernia, thereby underwent open repair with explant of bard flat mesh (device 1) and implant of bard flat mesh (device 2).Per op notes, ¿the hernia sac was identified in the abdominal region and was dissected.The mesh was found incorporated into the hernia sac.A sac along with the entirety of the first piece of mesh bard flat mesh (device 1) from original anterior repair was excised.The other mesh (synthetic mesh) from the laparoscopic ventral repair was also excised.A bard flat mesh (device 2) was placed within the retrorectus space and sutured¿.(b)(6) 2019- patient was diagnosed with recurrent incisional hernia, thereby underwent laparoscopic repair with implant of synthetic mesh.Per op notes, ¿the defect was noted in the umbilical region just superior to the previous mesh placed in retrorectus space.A synthetic mesh was placed and sutured¿.

• 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: 24377148
• Report Number: 1213643-2026-00161
• Device Sequence Number: 5650013
• Product Code: FTL
• UDI-Device Identifier: 00801741016561
• UDI-Public: (01)00801741016561(17)200328(10)HUZD0167
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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: 03/28/2020
• Device Catalogue Number: 0112720
• Device Lot Number: HUZD0167
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2015
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 109 KG