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

Catalog Number	5959812
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348); Disability (2371); Obstruction/Occlusion (2422)
Date of Event	08/25/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol sepramesh ip (device #2).Additional emdrs were submitted to represent the bard/davol composix kugel hernia patch (device #1) and ventralex st (device #3).Should additional information be provided, a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol composix kugel hernia patch, sepramesh composite ip and ventralex st on (b)(6) 2007 and/or (b)(6) 2010 and/or (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against all devices.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol composix kugel hernia patch, sepramesh composite ip and ventralex st on (b)(6) 2007 and/or (b)(6) 2010 and/or (b)(6) 2014.As reported, the patient is making a claim for an adverse patient outcome against all devices.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2007 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent open repair with the implant of composix kugel mesh (device 1).Per op notes, ¿the patient had multiple recurrent incisional hernias and another recurrence to right of prior synthetic mesh.The hernia sac was dissected, and the prior synthetic mesh was pulled away from fascia.A small composix kugel (device 1) was placed to bridge the fascial defect and sutured.¿ (b)(6) 2010 ¿ patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic to open repair with the removal of mesh (device 1) and implant of sepramesh ip (device 2).Per op notes, ¿the adhesions inferiorly and a herniation inferior to incision.There were small bowel loops of multiple that were densely adherent to both synthetic mesh in the umbilicus and to the composix kugel mesh (device 1) in the right upper umbilicus quadrant and synthetic mesh in left upper quadrant.All the meshes (device 1) were removed.The resultant abdominal wall defect within the fascia in right upper quadrant.A piece of sepramesh ip (device 2) was placed within the abdominal wall and secured using absorbable tacks.¿ (b)(6) 2014 ¿ patient was diagnosed with recurrent abdominal wall hernia; obstruction thereby underwent laparoscopic and open repair with the implant of ventralex st mesh (device 3).Per op notes, ¿the hernia sac was dissected from subcutaneous tissue down to the fascia.There was a eventration of abdominal wall.Adhesion to the hernia sac and small bowel, mesh.The previously placed sepramesh ip (device 2) had pulled away medially from the abdominal wall at the right superior edge of mesh.A round ventralex st patch (device 3) was placed within peritoneal cavity and sutured circumferentially to fascia and previous mesh (device 2) medially.¿.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: this supplemental emdr is submitted to document additional information provided.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-jun-2010) is considered to be a best estimate.This supplemental emdr represents the bard/davol sepramesh ip (device 2).Additional supplemental emdrs were submitted to represent the bard/davol mesh - composix kugel (device 1) and ventralex st (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 ; 4018258495
• MDR Report Key: 11279745
• Report Number: 1213643-2021-00800
• Device Sequence Number: 2736902
• Product Code: FTL
• UDI-Device Identifier: 00801741031830
• UDI-Public: (01)00801741031830(17)120628(10)HUUF1015
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: 06/28/2012
• Device Catalogue Number: 5959812
• Device Lot Number: HUUF1015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2010
• 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: Disability; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male