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

Catalog Number	5959360
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Hernia (2240)
Date of Event	06/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Per additional information provided: (b)(6) 2006 - patient was diagnosed with ventral hernia and abdominal pain thereby underwent open repair with the implant of composix mesh (device #1).Per operative notes, ¿a composix mesh (device #1) was placed and secured by sutures.¿ (b)(6) 2006 - patient was diagnosed with incarcerated recurrent incisional hernia and seroma thereby underwent open repair with explant of composix mesh (device #1).Per operative notes, ¿seroma was noted to be drained into the abdomen.A composix mesh (device #1) was completely removed from the lower abdominal wall.Then a synthetic mesh was used and secured by sutures.¿ (b)(6) 2007 - patient was diagnosed with recurrent incisional hernia thereby underwent open repair.Per operative notes, ¿scar tissue and hematoma was noted, and adhesions were taken down.Large recurrent incisional hernia was noted.Previously placed mesh was identified over the lower abdomen.Then another synthetic mesh was inserted behind the muscle using sutures.¿ (b)(6) 2008 - patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the implant of sepramesh ip (device #2).Per operative notes, ¿adhesions in the anterior abdominal wall were taken down and multiple hernias containing bowel were identified.A piece of sepramesh ip (device #2) was secured in place using sutures.¿ (b)(6) 2009 - patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of sepramesh ip (device #3).Per operative notes, ¿previously placed mesh (device #2) was noted.Then a sepramesh ip (device #3) was placed and secured by sutures.¿ (b)(6) 2012 - patient was diagnosed with recurrent incisional hernia and adhesions thereby underwent open repair.Per operative notes, ¿omentum and bowel was taken down.Then a synthetic mesh was placed and secured by sutures.¿ (b)(6) 2017 - patient was diagnosed with fistula and infection thereby underwent open repair with removal of mesh (device #2 & device #3).Per operative notes, ¿dense adherence of omentum to the old mesh was removed.All the previously placed meshes were removed.Then a biologic mesh was placed and secured by sutures.¿ (b)(6) 2018 - patient was diagnosed with fistula thereby underwent open repair.Per operative notes, ¿wound was irrigated and fistula plug was placed, secured by sutures.¿ (b)(6) 2018 - patient was diagnosed with fistula thereby underwent open repair.Per operative notes, ¿wound was irrigated and fistula plug was placed, secured by sutures.¿.
Additional Manufacturer Narrative
Addendum: 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 emdr represents the sepramesh ip (device #3).Additional supplemental emdr's were submitted to represent the mesh-composix (device #1) and 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.

• 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 ; 4018258495
• MDR Report Key: 21961836
• Report Number: 1213643-2025-090201
• Device Sequence Number: 15241661
• Product Code: FTL
• UDI-Device Identifier: 00801741031809
• UDI-Public: (01)00801741031809(17)110228(10)WBTHS116
• 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: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2025

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: 02/28/2011
• Device Catalogue Number: 5959360
• Device Lot Number: WBTHS116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 102 KG