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

Catalog Number	5959680
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	05/24/2018
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.This emdr was submitted to represent the bard/davol sepramesh ip (device #3).Additional supplemental emdr represents the bard/davol mesh ¿ composix kugel (device #1) and supplemental emdr was submitted to represent the bard/davol mesh ¿ composix kugel (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.
Event or Problem Description
Per information provided: on (b)(6) 2007 - patient was diagnosed with left lumbar hernia thereby underwent open repair with implant of composix kugel (device #1).Per op notes, "a composix kugel (device #1) was placed and tacked." on (b)(6) 2008 - patient was diagnosed with ilioinguinal nerve entrapment with retroperitoneal scarring, pain thereby underwent division of left ilioinguinal nerve.On (b)(6) 2008 - patient was diagnosed with recurrent left lumbar hernia thereby underwent laparoscopic repair with implant of composix kugel (device #2).Per op notes, "the previously paced mesh (device #1) appeared to be intact.A composix kugel (device #2) was placed and sutured." on (b)(6) 2008 - patient was diagnosed with infected mesh (device #1), hematoma thereby underwent partial removal of composix kugel (device #1).Per op notes, "the densely adherent composix kugel (device #1) was dissected and removed in two pieces." on (b)(6) 2010 - patient was diagnosed with recurrent left lumbar hernia thereby underwent laparoscopic repair with removal of composix kugel (device #1) and implant of sepramesh ip (device #3).Per op notes, "the previously placed mesh (device #1) appeared to be buckled up was dissected free from its adhesive attachments and removed.A sepramesh ip (device #3) was placed and sutured." on (b)(6) 2018 - patient was diagnosed with incarcerated recurrent incisional hernia thereby underwent robotic repair with explant of meshes (device #2 & #3) and implant of phasix mesh (device #4).Per op notes, "multiple adhesions on the midline were taken down.The meshes (device #2 & #3) were explanted.A phasix mesh (device #4) was placed 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: 22160565
• Report Number: 1213643-2025-00436
• Device Sequence Number: 12617859
• Product Code: FTL
• UDI-Device Identifier: 00801741031823
• UDI-Public: (01)00801741031823(17)110128(10)WBTGS103
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2025

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: 01/28/2011
• Device Catalogue Number: 5959680
• Device Lot Number: WBTGS103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 06/06/2025
• 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: 55 YR
• Patient Sex: Female