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

Catalog Number	0117010
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	04/12/2018
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-jan-2018) is considered to be a best estimate.This emdr was submitted to represent the bard soft mesh (device #2).An additional supplemental emdr submitted to represent the bard/davol mesh ¿ composix kugel (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: on (b)(6) 2005 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of composix kugel mesh.Per operative notes, ¿large scarred hernia sac was identified, dissected circumferentially and removed.A composix kugel mesh was placed for the repair and secured with sutures.¿ on (b)(6) 2018 - patient was diagnosed with recurrent symptomatic incisional hernia thereby underwent laparoscopic converted to open repair with bard soft mesh (device # 2).Per operative notes, ¿the loops of small bowel adherent to the mesh (device #1) were removed.The old mesh (device # 1) appeared to be intact.The sac was dissected circumferentially and resected.The fascial defect closed with sutures and bard soft mesh (device #2) was placed and secured circumferentially with sutures.¿ on (b)(6) 2018 - patient was diagnosed with recurrent incisional hernia and small bowel obstruction and adhesion thereby underwent open repair with removal of previously placed mesh (device # 1 and # 2) and implant of synthetic mesh.Per operative notes, ¿the small bowel was seen adhered to the mesh.The interloop adhesions and kugel mesh (device # 1) was removed and sutured.The fascial defect of the recurrent hernia was encountered, and recently placed mesh (device # 2) was excised.The defect was closed with sutures and synthetic mesh was placed over the incisional hernia repair and sutured.¿.

• Brand Name: BARD SOFT 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: 22410413
• Report Number: 1213643-2025-00577
• Device Sequence Number: 8407341
• Product Code: FTL
• UDI-Device Identifier: 00801741030871
• UDI-Public: (01)00801741030871(17)230128(10)HUCN1750
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 06/20/2025

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: 01/28/2023
• Device Catalogue Number: 0117010
• Device Lot Number: HUCN1750
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2018
• 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: Female