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

Catalog Number	5959680
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Scar Tissue (2060); Hernia (2240)
Date of Event	06/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2005 ¿ patient was diagnosed with ventral hernia thereby underwent open repair with the implant of sepramesh ip (device 1).Per op notes, ¿multiple hernia defect in midline were encountered.The sepramesh ip (device 1) was laid on the top of fascia and sutured.¿ on (b)(6) 2013 ¿ patient had pain and was diagnosed with incarcerated ventral and incisional hernia; umbilical hernia thereby underwent open repair with the implant of ventralex patch (device 2).Per op notes, ¿previous upper midline abdominal incision extended to the superior aspect of the umbilicus.The scar tissue was taken off.The hernia sac was noted with some necrotic omentum.There were some adhesions to the abdominal wall with the small bowel.A small umbilical hernia was noted.A ventralex mesh (device 2) was placed underlay and affixed to the abdominal wall using suture.¿ (note: there was no mention/visualization of device 1 in this procedure) on (b)(6) 2015 ¿ patient was diagnosed with ventral incisional hernia thereby underwent open repair with the implant of synthetic mesh.Per op notes, ¿the hernia sac was more to the left of the midline incision.The previous mesh repair inferior to the hernia defect and to the lower right side was noted.There was some small bowel appeared to be adjacent to mesh (device 1, 2) was adherent was taken down.Onlay synthetic mesh was placed overlying the defect and tacked down.¿ on (b)(6) 2019 ¿ patient was diagnosed with adhesion, incisional hernia and recurrent umbilical hernia thereby underwent robotic repair with the partial removal of mesh (device 1, 2) and implant of ventralight st mesh using echo ps (device 3).Per op notes, ¿severe adhesion to the omentum and small bowel and old mesh were taken down.The bowel was resected.Three hernias were noted.The old mesh (device 1, 2) appeared to be well incorporated, and lower half was not incorporated was removed.A ventralight st using echo ps (device 3) was placed into abdomen and secured to defect using suture.¿ on (b)(6) 2019 ¿ patient was diagnosed with infected abdominal mesh thereby underwent open repair with the partial removal of mesh (device 3).Per op notes, ¿the bowel and omentum were severely adhered to anterior abdominal wall.A large fluid collection was drained.The mesh was not well incorporated at all and there was a small fluid collection superior to the mesh was drained.The mesh (device 3) was excised.The jejunal seromuscular patch was created.¿ on (b)(6) 2020 ¿ patient was diagnosed with recurrent incisional hernias, rectus diastasis, fistula, chronic mesh infection thereby underwent open repair with the removal of meshes (device 1, 2, 3).Per op notes, ¿a site of chronic drainage consistent with chronic mesh infection and entero-prosthetic fistula.Adhesions were encountered.The small bowel was resected along with mesh (device 1, 2, 3).A hernia defected was found and a synthetic mesh was placed in retro rectus and preperitoneal space using sutures.¿ on (b)(6) 2020 ¿ patient had hematoma in abdominal wall thereby underwent evacuation of hematoma.
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.The mdr represents the sepramesh ip (device 1).An additional mdr was submitted to represent the bard/davol ventralight st using echo ps (device 3) and supplemental emdr was submitted to represent ventralex mesh (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.

• 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: 23897326
• Report Number: 1213643-2025-01280
• Device Sequence Number: 20081013
• Product Code: FTL
• UDI-Device Identifier: 00801741031823
• UDI-Public: (01)00801741031823(10)04NP382US
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/24/2025

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 Catalogue Number: 5959680
• Device Lot Number: 04NP382US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/26/2025
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 101 KG