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); Purulent Discharge (1812); Unspecified Infection (1930)
Date of Event	06/28/2021
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-jan-2016) is considered to be a best estimate.This mdr represents the sepramesh ip (device 2).An additional supplemental emdr was submitted to represent the ventrio mesh (device 1).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 incisional hernia thereby underwent open repair with the implant of ventrio mesh (device 1).Per op notes, ¿a small defect was noted at the superior aspect of previous chevron incision.The hernia was reduced and another two defects were noted at inferior aspect.A ventrio mesh (device 1) was placed to cover the entire length of incision by incorporating all the defects using sutures.¿ (b)(6) 2016 ¿ patient was diagnosed with recurrent ventral incisional hernia thereby underwent laparoscopic repair with partial removal of mesh (device 1) and implant of sepramesh ip (device 2).Per op notes, ¿patient had dense adhesions between the bowel, the omentum, abdominal wall, and prior mesh were lysed.The mesh (device 1) not incorporated to abdominal wall was debrided away.The incisional hernia was noted along the costal margin with innumerable small and medium sized defects.A sepramesh ip (device 2) was placed to the defect and secured using tacks.¿ (b)(6) 2021 ¿ patient was diagnosed with mesh infection and chronic draining sinus thereby underwent open repair with the removal of mesh (device 1) and partial removal of mesh (device 2).Per op notes, ¿draining sinus was noted in epigastric region.A small pock purulence was encountered.Adhesion was lysed.The infected skin, mesh and tissue were explanted partially.The mesh (device 2) had overlap on defect was left in place.¿.

• 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: 24320789
• Report Number: 1213643-2026-00110
• Device Sequence Number: 9674585
• Product Code: FTL
• UDI-Device Identifier: 00801741031830
• UDI-Public: (01)00801741031830(17)180128(10)HUAN0090
• 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: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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: 01/28/2018
• Device Catalogue Number: 5959812
• Device Lot Number: HUAN0090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2016
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 69 KG