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

Catalog Number	5959480
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	11/08/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2008 ¿ patent was diagnosed with incisional hernia thereby underwent open repair with the implant of sepramesh ip (device 1).Per op notes, ¿the hernia sac was closed and preperitoneal space was developed.A sepramesh ip (device 1) was placed in the standard position and transfixed with sutures.¿ on (b)(6) 2012 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of sepramesh ip (device 2).Per op notes, ¿the hernia sac was identified, and the right side of the mesh (device 1) had pulled away from the fascia and created a defect which allowed recurrent hernia to appear.A plane was created above the previous mesh (device 1) and a sepramesh ip (device 2) was placed in the intra-abdominal position with the smooth area towards the bowel and transfixed using sutures.¿ on (b)(6) 2016 ¿ patient was diagnosed with incarcerated ventral hernia thereby underwent open repair with the partial removal of mesh (device 1, 2).Per op notes, ¿the mesh (device 1, 2) incorporated into hernia sac was dissected down.There was more (device 1, 2) mesh on the anterior abdominal wall superiorly adherent to omentum.Adhesion was taken down.At least two-thirds of the circumference of the defect was already composed of mesh densely adherent into the fascia.The patient had failed two previous mesh repairs due to patient body habitus.¿ on (b)(6) 2019 ¿ patient was diagnosed with recurrent ventral incisional hernia thereby underwent open repair with the partial removal of mesh (device 1, 2) and implant of ventrio st mesh (device 3).Per op notes, ¿extensive scarring was present.Two defects were divided and a previously placed polypropyelene type mesh (device 1, 2) was identified at superior aspect of mesh.Some of mesh (device 1, 2) not incorporated was removed.Adhesions were taken down.A ventrio st patch (device 3) was positioned within intraabdominal space and secured to previous mesh using sutures.¿.
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-dec-2011) is considered to be a best estimate.This emdr represents the bd sepramesh ip (device 2).An additional supplemental emdr was submitted to represent the bd sepramesh ip (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.

• 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: 23553278
• Report Number: 1213643-2025-01093
• Device Sequence Number: 13205429
• Product Code: FTL
• UDI-Device Identifier: 00801741031816
• UDI-Public: (01)00801741031816(17)131228(10)HUVL0959
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/12/2025

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: 12/28/2013
• Device Catalogue Number: 5959480
• Device Lot Number: HUVL0959
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2011
• 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