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

Catalog Number	5959480
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	02/12/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per additional information provided: on (b)(6) 2012 - patient was diagnosed with incarcerated incisional hernia thereby underwent laparoscopic repair with the implant of sepramesh ip (device 1).Per op notes, "the hernia was noted in the lower portion of the abdomen.A sepramesh ip (device 1) was placed to the anterior abdominal wall using sutures." on (b)(6) 2012 - patient was diagnosed with symptomatic incarcerated ventral hernia thereby underwent open repair with the implant of sepramesh ip (device 2) and lysis of adhesions.Per op notes, "a vertical midline incision was made to the prior scar, extensive adhesiolysis was performed.A sepramesh ip (device 2) was placed using prolene sutures.Once the mesh was in place, the superior aspect of old hernia site was closed with additional prolene sutures." on (b)(6) 2016 - patient was diagnosed with incarcerated recurrent incisional hernia with small bowel obstruction thereby underwent open repair with the implant of ventralight st mesh (device 3) and lysis of adhesions.Per op notes, "extensive lysis of adhesions within the hernia sac to free the bowel.Identified the prior mesh (device 1 and 2), it appeared to have folded up on itself and was located superiorly within the hernia sac.A ventralight st mesh (device 3) was secured to the prior mesh superiorly.".
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-oct-2012) is considered to be a best estimate.This emdr represents the sepramesh ip (device 2).An additional supplemental emdr was submitted to represent the bard/davol 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: 24018308
• Report Number: 1213643-2026-00011
• Device Sequence Number: 16088382
• Product Code: FTL
• UDI-Device Identifier: 00801741031816
• UDI-Public: (01)00801741031816(17)141028(10)HUWJ1184
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2026

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: 10/28/2014
• Device Catalogue Number: 5959480
• Device Lot Number: HUWJ1184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2012
• 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: 60 YR
• Patient Sex: Female