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

Catalog Number	5959480
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	08/01/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2015: patient was diagnosed with incisional hernia thereby underwent open repair with implant of sepramesh ip (device 1).Per op notes, ¿the old scar was removed.The hernia sac was identified and reduced.A sepramesh ip (device 1) was placed over the defect and secured using prolene sutures.¿ on (b)(6) 2015: patient was diagnosed with recurrent incisional hernia and right inguinal hernia thereby underwent open repair with excision of sepramesh ip (device 1) and implant of sepramesh ip (device 2) and perfix plug (device 3).Per op notes, ¿the scar tissue from previous incisional hernia in epigastrium was excised.The mesh was identified and torn away from the fascia.The mesh (device 1) was excised.A sepramesh ip (device 2) was placed and sutured.An indirect hernia sac was identified on right groin and reduced.A perfix plug (device 3) with onlay patch was placed and sutured.¿ (b)(6) 2016: patient was diagnosed with recurrent ventral hernia thereby underwent robotic assisted repair with implant of synthetic mesh.Per op notes, ¿a large recurrent defect was identified and contains omentum.The omentum was reduced.The prior mesh (device 2) was noted.A synthetic mesh was placed and tacked using optifix tacker.¿.
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-mar-2015) is considered to be a best estimate.This mdr represents the sepramesh ip (device 2).An additional emdr was submitted to represent the sepramesh ip (device 1).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: 24744835
• Report Number: 1213643-2026-00408
• Device Sequence Number: 12947618
• Product Code: FTL
• UDI-Device Identifier: 00801741031816
• UDI-Public: (01)00801741031816(17)170328(10)HUZC0141
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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: 03/28/2017
• Device Catalogue Number: 5959480
• Device Lot Number: HUZC0141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2015
• 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: 54 YR
• Patient Sex: Male