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); Ischemia (1942); Hernia (2240)
Date of Event	10/25/2018
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-aug-2010) is considered to be a best estimate.This mdr represents sepramesh ip (device 2).Additional supplemental emdr's were submitted to represent the composix kugel mesh (device 1) and ventrio st mesh (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 ventral incisional hernia thereby underwent open repair with implant of composix kugel mesh (device 1).Per operative notes, in the midline, hernia sac was excised and adhesions were reduced.The large composix kugel mesh (device 1) was placed over the defect and secured with sutures and tacks.¿ (b)(6) 2010 ¿ patient was diagnosed with incarcerated recurrent ventral incisional hernia and pain thereby underwent laparoscopic repair with implant of sepramesh ip mesh (device 2).Per operative notes, ¿the significant amount of adhesions involving mesh (device 1) and small bowel were lysed.The hernia contents were reduced and sepramesh ip (device 2) was placed over the hernia defect and sutured.¿ (b)(6) 2018 ¿ patient was diagnosed with left flank incisional hernia thereby underwent robotic repair with removal of composix kugel mesh (device 1) and implant of ventrio st mesh (device 3).Per operative notes, ¿the old mesh (device 1) was seen contracted and wadded up superfascial to previous mesh (device 2).The mesh (device 1) was removed.The overlying skin in this area was thinned and ischemic.Adhesions of anterior abdominal wall was lysed.The left flank incisional hernia was repaired with ventrio st mesh (device 3) and sutured.The fascia was closed and sutured.¿.

• 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: 23616605
• Report Number: 1213643-2025-01112
• Device Sequence Number: 9072564
• Product Code: FTL
• UDI-Device Identifier: 00801741031830
• UDI-Public: (01)00801741031830(17)120828(10)HUUH1079
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 11/19/2025

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: 08/28/2012
• Device Catalogue Number: 5959812
• Device Lot Number: HUUH1079
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2010
• 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: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female