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

Catalog Number	5959360
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Fistula (1862); Unspecified Infection (1930); Hernia (2240)
Date of Event	04/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2008 ¿ patient was diagnosed with recurrent incarcerated spigelian /abdominal wall hernia thereby underwent laparoscopic repair with implant of sepramesh ip (device #1).Per op notes, ¿the hernia sac was identified with incarcerated bowel.All the bowel was reduced.A sepramesh ip (device #1) was placed and tacked.¿ (b)(6) 2014 - patient was diagnosed with recurrent spigelian/lateral abdominal wall hernia thereby underwent laparoscopic repair with implant of perfix plug (device #2 & #3) and sepramesh ip (device #4).Per op notes, ¿a large hernia sac in the right upper quadrant was identified with incarcerated bowel.The bowel was reduced.The sac was excised.Two perfix plugs (device #2 & #3) were placed next to each other and tacked.A sepramesh ip (device #4) was placed as an overlay mesh and tacked.¿ (b)(6) 2019 - patient was diagnosed with recurrent incarcerated right lower quadrant spigelian hernia with abscess thereby underwent repair with drainage of abscess.Per op notes, ¿the hernia sac was identified and not reducible contains bowel.The bowel was reduced hardly.The sac was excised.The prior meshes (device #1, #2, #3 & #4) were identified.Several loops of bowel densely adherent to prior meshes were lysed.A yellowish green fluid oozed out of cavity.The abscess cavity was drained.The hernia defect was repaired with sutures.¿ (b)(6) 2020 - patient was diagnosed with rlq abdominal wall abscess and infected meshes (device #1, #2, #3 & #4) thereby underwent open repair with partial excision of perfix plug (device #2 & #3) and sepramesh ip (device #1 & #4).Per op notes, ¿the sinus tract was found medially towards the abscess.The sinus tract was excised.The scar tissue was excised.The abscess cavity was opened and drained.The wadded prior meshes (device #1, #2, #3 & #4) identified inferior to abscess cavity was partially excised and removed.Wound vac was placed and sutured.¿.
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 #1).An additional mdr was submitted to represent the perfix plug (device #3).Additional supplemental emdr's were submitted to represent the perfix plug (device #2), sepramesh ip (device #4).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: 22663356
• Report Number: 1213643-2025-00694
• Device Sequence Number: 7533947
• Product Code: FTL
• UDI-Device Identifier: 00801741031809
• UDI-Public: (01)00801741031809
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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): 07/25/2025

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: 5959360
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 07/30/2025
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 119 KG