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

Catalog Number	5959812
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240)
Date of Event	11/09/2009
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 sepramesh ip (device #3).An additional supplemental emdr was submitted to represent the bard/davol mesh -composix e/x (device #1), and sepramesh ip (device #2).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 additional information provided: (b)(6) 2007 ¿ patient was diagnosed with ventral incisional hernia thereby underwent open repair with the implant of composix e/x mesh (device 1).Per op notes, ¿the ventral hernia defect covered the entire area from the umbilicus to the suprapubic region.A composix e/x mesh (device 1) was laid with smooth surface towards the intestine and rougher surface anteriorly using sutures." (b)(6) 2009 ¿ patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with the removal of mesh (device 1) and implant of sepramesh ip (device 2).Per op notes, ¿infraumbilical scar was dissected.Most of the mesh (device 1) was intact except for the inferior part which had pulled off.The previous mesh (device 1) was removed.Adhesions were released.A sepramesh ip (device 2) was placed in the space between the bladder and suprapubic region using sutures.¿ (b)(6) 2009 ¿ patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with the removal of mesh (device 2) and implant of sepramesh ip (device 3).Per op notes, ¿the previous mesh (device 2) had pulled apart in most of its edges and torn apart because of traumatic injury and fall.The mesh (device 2) was removed.A piece of sepramesh ip (device 3) was deployed into defect and tacked using sorbafix tacks.¿ (b)(6) 2009 - patient was diagnosed with complex recurrent ventral incisional hernia thereby underwent open repair with the removal of mesh (device 3).Per op notes, ¿midline scar was removed.Lysis of adhesion and old mesh (device 3) which was partially disrupted was completely removed.The resulting ventral hernia defect was closed with large synthetic mesh.".

• Brand Name: SEPRAMESH IP
• 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: 23422471
• Report Number: 1213643-2025-01035
• Device Sequence Number: 15918447
• Product Code: FTL
• UDI-Device Identifier: 00801741031830
• UDI-Public: (01)00801741031830(10)WBSAS040
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2025

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: Other
• Device Catalogue Number: 5959812
• Device Lot Number: WBSAS040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 10/30/2025
• 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: 53 YR
• Patient Sex: Female