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

Catalog Number	5959480
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240)
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2012 - patient was diagnosed with recurrent left inguinal hernia and right inguinal hernia thereby underwent laparoscopic repair with the implant of 3dmax meshes (device #1 & #2).Per operative notes, "on the right side, the hernia sac was identified and dissected out the direct hernia.Attention was given to left side; some scarring was noted and a hernia was noted within the muscles of anterior abdominal wall.A 3dmax mesh (device #1 & #2) was folded and placed in preperitoneal space.Similar procedure was done on right side.The umbilical hernia was identified and fixed by pushing the omentum back and sutured." (b)(6) 2013 - patient was diagnosed with supraumbilical ventral hernia thereby underwent open repair with the implant of ventralex st mesh (device #3).Per operative notes, "the fascial edges were identified and dissected free and the herniated tissue was put back in peritoneal cavity.A ventralex st (device #3) was placed and sutured to the fascial edges." (b)(6) 2013 - patient was diagnosed with recurrent ventral hernia thereby underwent open and laparoscopic repair with explant of ventralex st (device #3) and implant of sepramesh ip (device #4).Per operative notes, "the ventralex st (device #3) was seen and completely removed.The hernia defect was seen along with some diastasis.A sepramesh ip (device #4) was placed in peritoneal cavity and pulled into the anterior abdominal wall and tacked." attorney alleges that the patient had pain, hernia recurrence between (b)(6) 2013 to (b)(6) 2014.It is also alleged that the patient had stomach bulges which requires wearing of large elastic belt at all times and also limited activity to avoid stressing abdominal muscles between (b)(6) 2016, (b)(6) 2017 and the present.
Additional Manufacturer Narrative
Based on the information received, no conclusions can be made.Per medical records review, about post implant of sepramesh ip, patient was diagnosed with hernia recurrence and pain.The instructions-for-use supplied with the device lists hernia recurrence and pain as possible complications.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the sepramesh ip (device #4).An additional supplemental emdr was submitted to represent the ventralex st (device #3).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.H3 other text: not returned.

• Brand Name: SEPRAMESH IP
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: 21371807
• Report Number: 1213643-2025-090074
• Device Sequence Number: 3759280
• Product Code: FTL
• UDI-Device Identifier: 00801741031816
• UDI-Public: (01)00801741031816
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2025

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 Catalogue Number: 5959480
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 02/13/2025
• 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 Sex: Male