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 Code	Hernia (2240)
Date of Event	09/09/2020
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 3).An additional supplemental emdr for bard flat mesh (device 1) and emdrs were submitted to represent bard flat meshes (2 & 5) and ventralex st mesh (device 4).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 recurrent right inguinal hernia thereby underwent laparoscopic repair with the implant of bard flat mesh (device 1).Per op notes, "direct right inguinal hernia was noted.A bard flat mesh (device 1) was placed into the floor of canal of inguinal canal superior to epigastric vessels and pubic tubercle using sutures." (b)(6) 2018 - patient was diagnosed with left inguinal hernia thereby underwent laparoscopic repair with the implant of bard flat mesh (device 2).Per op notes, ¿a large defect was noted just medial to the internal ring.A bard flat mesh (device 2) was placed over the floor of inguinal canal and sutured.¿ (b)(6) 2019 - patient was diagnosed with recurrent left inguinal hernia thereby underwent laparoscopic repair with the bard flat mesh (device 3).Per op notes, "the right-sided laparoscopic inguinal hernia repair was intact.On left, direct inguinal hernia was identified.A bard flat mesh (device 3) was placed in the abdomen within the preperitoneal space.A synthetic mesh was situated in place and peritoneum and closed overusing tacks." (b)(6) 2019 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with the implant of ventralex st mesh (device 4) and implant of bard flat mesh (device 5).Per op notes, "a large hernia defect was encountered.A round ventralex st mesh (device 4) was placed to surrounding fascia and second piece of bard flat mesh (device 5) was placed over the mesh and secured using sutures." (b)(6) 2020 - patient was diagnosed with incarcerated ventral hernia, recurrent left inguinal hernia thereby underwent robotic repair with the removal of meshes (device 2, 3, 4, 5) and implant of bard flat mesh (device 6).Per op notes, "a recurrent left hernia was identified, and the peritoneal flap was dissected free from the transversalis fascia and abdominal wall.The bard flat mesh (device 6) was used to cover the entire myopectineal orifice and direct, indirect, and femoral spaces completely.Several pieces of mesh (device 2, 3, 4, 5) was resected.On contralateral right side, no overt hernia was noted and prior mesh (device 1) was encountered.An incarcerated ventral hernia was noted in typical spigelian was closed with marlex mesh using sutures.".

• 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: 25358699
• Report Number: 1213643-2026-00698
• Device Sequence Number: 10729460
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K251557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/02/2026
• 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: 67 YR
• Patient Sex: Male