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	Adhesion(s) (1695); Fistula (1862); Bowel Perforation (2668)
Date of Event	08/03/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2007 - patient was diagnosed with ventral hernia, umbilical hernia and left inguinal hernia thereby underwent laparoscopic repair with implant of composix e/x mesh (device 1), ventralex mesh (device 2), bard mesh pre-shaped with keyhole (device 3) and sepramesh ip (device 4).Per op notes, ¿cystoscopy was performed.Small bowel adherent to the midline from the falciform ligament down towards the bladder was taken down.The serosa was repaired with sutures.Adhesions between the sigmoid colon was removed from the incarcerated left inguinal hernia.A bard mesh pre-shaped with keyhole (device 3) and a composix e/x (device 1) were placed in the left inguinal area and secured with sutures.The umbilical hernia was then closed with a ventralex mesh (device 2).A sepramesh ip (device 4) was placed intraabdominally for the repair of ventral hernia and stapled to the anterior abdominal wall.¿ on (b)(6) 2015 - patient was diagnosed with small bowel fistula to the overlying mesh thereby underwent open repair with excision of ventralex mesh (device 2) and sepramesh ip (device 4).Per op notes, ¿an incision was made in the lower abdomen below the mesh.The mesh (device 2 and 4) was dissected to remove the entire piece.Two areas of small bowel matted to the mesh were resected.Appendectomy was performed.¿ on (b)(6) 2015 ¿ patient was diagnosed with staple line leak thereby underwent exploratory laparotomy, irrigation of abdomen and resection of distal small bowel anastomosis.
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 mdr represents the sepramesh ip (device 4).Additional supplemental emdr¿s were submitted to represent the composix e/x mesh (device 1), ventralex mesh (device 2), bard mesh pre-shaped with keyhole (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: 24377622
• Report Number: 1213643-2026-00167
• Device Sequence Number: 11971311
• Product Code: FTL
• UDI-Device Identifier: 00801741031823
• UDI-Public: (01)00801741031823(17)070828(10)06NP222
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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: 08/28/2007
• Device Catalogue Number: 5959680
• Device Lot Number: 06NP222
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 02/18/2026
• 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: 60 YR
• Patient Sex: Female