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

Catalog Number	5959680
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	12/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2005: patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the implant of composix kugel mesh (device 1).Per op notes, "the hernia rent was noted in midline.A large composix kugel patch (device 1) was placed in abdominal cavity with ptfe and secured using tacks." on (b)(6) 2005: patient was diagnosed with recurrent ventral incisional hernia; adhesion thereby underwent laparoscopic repair with the implant of sepramesh ip (device 2).Per op notes, "the recurrence was noted right of midline below the umbilicus.Adhesion to previous mesh (device 1) was taken down.A large sepramesh ip (device 2) was trimmed in oval fashion and placed into peritoneal cavity and tacked." on (b)(6) 2019: patient was diagnosed with incisional hernia thereby underwent open repair with the implant of ventrio st mesh (device 3).Per op notes, "the incisional hernia was on the epigastrium at the site of previous right subcostal incision from open cholecystectomy.The inferiorly placed hernia mesh (device 2) from lower abdominal incisional hernia was noted.Adhesions to the mesh itself which were left in situ.A ventrio st mesh (device 3) was placed into intra-abdominal cavity and laid against anterior abdominal wall using tacks." on (b)(6) 2019: patient was diagnosed with multiply recurrent incarcerated incisional hernia, bilateral inguinal hernia thereby underwent open repair with the removal of mesh (device 1, 2) and implant of ventrio st mesh (device 4) and bard flat mesh (device 5).Per op notes, "the mesh (device 1, 2) within the subcutaneous tissues appeared completely eventrated into the soft tissues and not adherent to intact fascia.Two big pieces of mesh likely a second piece that had been placed laparoscopically over the first.The mesh (device 1) was adherent to the anterior abdominal wall and the second mesh (device 2) was adherent to the underlying omentum and small bowel.All the meshes (device 1, 2) were removed.Previous mesh (device 3) in the epigastric region appeared to be in good position without evidence of recurrence.A ventrio st mesh (device 4) was placed into intraabdominal cavity to underlay the midline fascial defect using tacks.Attention to bilateral inguinal hernia, a bard flat mesh (device 5) was cut into two halves.Half of mesh was placed into right groin region.On left groin, similar repair was done using another half bard flat mesh (device 5) 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.This emdr represents the sepramesh ip (device 2).Additional emdr and supplemental emdr were submitted to represent the composix kugel mesh (device 1) and ventrio st mesh (device 3).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: 24996619
• Report Number: 1213643-2026-00564
• Device Sequence Number: 9034495
• Product Code: FTL
• UDI-Device Identifier: 00801741031823
• UDI-Public: (01)00801741031823(17)060328(10)05NP123US
• 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: 2005
• 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): 04/21/2026

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 Expiration Date: 03/28/2006
• Device Catalogue Number: 5959680
• Device Lot Number: 05NP123US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 04/27/2026
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 93 KG