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

Catalog Number	5959812
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	04/21/2014
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-feb-2010) is considered to be a best estimate.This mdr 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.
Event or Problem Description
Per information provided: (b)(6) 2010 ¿ patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent laparoscopic repair with implant of two sepramesh ip meshes (device 1 and 2).Per operative notes, ¿in the right lower quadrant midline, a large incisional hernia defect in right lower quadrant and periumbilical area was noted.Both defects were combined together and two sepramesh ip (device 1 and 2) was placed.The adhesions of omentum from anterior abdominal wall was lysed and fascia was closed with sutures and tacks circumferentially.¿ (b)(6) 2014 - patient was diagnosed with recurrent abdominal ventral hernia with adhesions thereby underwent open repair with partial removal of meshes (device 1 and 2).Per operative notes, ¿the recurrent hernia in the deep fascia of right lower quadrant was noted.The sac and part of meshes (device 1 and 2) were excised.Adhesions were sharply taken down and fascia was closed and sutured and stapled to previous meshes (device 1 and 2).(b)(6) 2018 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent open repair with implant of bard flat mesh (device 3).Per operative notes, ¿the hernia sac from the right of midline below the umbilicus to right lower quadrant towards anterior superior iliac spine was noted.The sac was completely dissected and adhesions of anterior abdominal wall was lysed.The fascia was closed and bard flat mesh (device 3) was placed over the defect and sutured to corners of prior mesh (device 1 and 2).The fascia was closed and new mesh (device 3) and prior meshes (device 1and 2) were sutured together.¿.

• 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: 23848479
• Report Number: 1213643-2025-01245
• Device Sequence Number: 13163615
• Product Code: FTL
• UDI-Device Identifier: 00801741031830
• UDI-Public: (01)00801741031830(17)120328(10)HUUB1082
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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: 03/28/2012
• Device Catalogue Number: 5959812
• Device Lot Number: HUUB1082
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2010
• 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: 39 YR
• Patient Sex: Female