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	07/30/2015
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.Note, the manufacturing date (15-may-2014) is considered to be a best estimate.This mdr represents the sepramesh ip (device 2).An additional supplemental 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.
Event or Problem Description
Per information provided: (b)(6) 2013 ¿ patient was diagnosed with ventral hernia thereby underwent laparoscopic repair with the implant of sepramesh ip (device 1).Per op notes, ¿the hernia was located in upper midline.A piece of sepramesh ip (device 1) was cut into circular pattern and utilized to over the fascial defect using sorbafix tacks.¿ (b)(6) 2014 ¿ patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the removal of mesh (device 1) and implant of sepramesh ip (device 2).Per op notes, ¿the hernia site was located in the midline above the umbilicus.There was some old mesh (device 1) had eventrated up into the hernia sac.The old mesh (device 1) was removed.A few adhesions were lysed.Bilateral muscle flaps were raised.A sepramesh ip (device 2) was placed in retromuscular position and sutured.¿ (b)(6) 2015 ¿ patient was diagnosed with recurrent incarcerated ventral hernia thereby underwent open repair with the implant of ventrio st mesh (device 3).Per op notes, ¿the hernia was located in the midline about at the level of the umbilicus.The hernia recurred just deeper to the level of the old mesh (device 2) was intact which was holding the upper wall.Adhesions were freed from the previous mesh.A piece of ventrio st mesh (device 3) was placed as overlay to fascial defect and secured using sorbafix tacks.¿.

• 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: 24207285
• Report Number: 1213643-2026-00049
• Device Sequence Number: 20211046
• Product Code: FTL
• UDI-Device Identifier: 00801741031823
• UDI-Public: (01)00801741031823(17)160528(10)HUYE0506
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2026

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: 05/28/2016
• Device Catalogue Number: 5959680
• Device Lot Number: HUYE0506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2014
• 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: 52 YR
• Patient Sex: Female