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	09/18/2018
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-jul-2011) is considered to be a best estimate.This mdr represents the sepramesh ip (device 3).An additional supplemental emdr was submitted to represent the sepramesh ip (device 1).An additional mdr was submitted to represent the sepramesh ip (device 2).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) 2012 - patient was diagnosed with incarcerated ventral incisional hernia upper midline, ventral incisional hernia lower midline, incarcerated ventral incisional hernia right lower quadrant thereby underwent laparoscopic repair with implant of sepramesh ip (device 1- upper midline, device 2 ¿ lower midline and device 3 ¿ right lower quadrant).Per operative notes, ¿the initial incision was made in the upper midline.The hernia sac was dissected out.A sepramesh ip (device 1) was placed into the upper midline of supraumbilical region and secure it with sutures.An incision was made into the lower midline.The hernia sac was dissected out.A sepramesh ip (device 2) was reinforced with (device 1) and tacked with tackers.Then attention was taken into the lower right quadrant.The hernia sac was dissected out.A sepramesh ip (device 3) was placed into right lower quadrant and secure it with sutures.¿ (b)(6) 2012 - patient was diagnosed with ventral incisional incarcerated hernia (upper midline), scar tissue, adhesion thereby underwent open repair with implant of ventralex mesh (device 4).Per operative notes, ¿an incision was made in the upper suprapubic midline.The hernia sac was dissected out.All scar tissues were taken down.There was dense amount of adhesion into the abdominal cavity.All adhesions were removed from abdomen.A ventralex mesh (device 4) was placed in the retroperitoneal space and secure it with sutures.¿ (b)(6) 2018 - patient was diagnosed with recurrent right lower quadrant ventral hernia, left lower quadrant ventral hernia, adhesion, thereby underwent open repair with explant of sepramesh ip (device 3) implant of two synthetic mesh.Per operative notes, ¿an incision was made into the tight lower ventral quadrant.The hernia sac was dissected out.Previously placed (device 3) was dissected out.There was dense amount of adhesion which was taken down.A synthetic mesh was placed into the right lower region.A similar dissected was done on the left side.The hernia sac was dissected out.A synthetic mesh was placed into the left lower quadrant and secure it with 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: 24480854
• Report Number: 1213643-2026-00256
• Device Sequence Number: 15779405
• Product Code: FTL
• UDI-Device Identifier: 00801741031830
• UDI-Public: (01)00801741031830(17)130728(10)HUVG1007
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2026

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: 07/28/2013
• Device Catalogue Number: 5959812
• Device Lot Number: HUVG1007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2011
• 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: 44 YR
• Patient Sex: Female