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

Catalog Number	5959680
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Purulent Discharge (1812); Fistula (1862); Unspecified Infection (1930)
Date of Event	09/14/2016
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-dec-2009) is considered to be a best estimate.This emdr represents the bard sepramesh ip (device #4).An additional emdr was submitted to represent the bard mesh - composix e/x (device #1) and additional supplemental emdrs were submitted to represent bard mesh - ventralex (device #2 and 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.
Event or Problem Description
Per information provided: (b)(6) 2009 ¿ patient was diagnosed with two incisional hernias thereby underwent laparoscopic repair with the implant of composix e/x mesh (device #1) and ventralex meshes (device #2, #3).Per op notes, ¿hernia in the midline of the abdomen adjacent to umbilicus was noted.A composix e/x mesh (device #1) was placed the defect and sutured.Then, second hernia was noted inferiorly was repaired using a ventralex mesh (device #2) and tacked to inferior abdominal wall.A weakened point was noted superior to second hernia was repaired with another ventralex mesh (device #3) and sutured.¿ (b)(6) 2010 ¿ patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with the implant of sepramesh ip (device #4).Per op notes, ¿a large amount of adhesions were noted in the midline of abdomen and significant herniation noted in supraumbilical area.A large piece of sepramesh ip (device #4) was placed into the supraumbilical hernia defect and tacked using sorbafix.¿ (b)(6) 2016 ¿ patient was diagnosed with infected mesh and enterocutaneous fistula, adhesions thereby underwent open repair with the removal of meshes (device #1, #2, #3, #4).Per op notes, ¿a large piece of mesh encompassing a large portion of the abdominal wall.There was a central area with bowel stuck to mesh with obvious infection and purulence.The mesh was removed with infected fascia.The small bowel included at least 3 fistulous to the abscess in the small bowel was resected and anastomosis was performed.All meshes (device #1, #2, #3, #4) were removed.The defect was repaired using sutures.¿.

• 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: 22492552
• Report Number: 1213643-2025-00622
• Device Sequence Number: 8094166
• Product Code: FTL
• UDI-Device Identifier: 00801741031823
• UDI-Public: (01)00801741031823(17)111228(10)HUTL0261
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2025

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: 12/28/2011
• Device Catalogue Number: 5959680
• Device Lot Number: HUTL0261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2009
• 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: 55 YR
• Patient Sex: Female