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

Catalog Number	5959812
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hernia (2240); Injury (2348)
Date of Event	09/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard/davol sepramesh ip (device #1).Additional emdrs were submitted to represent the bard/davol ventralex hernia patch (device #2) and bard/davol sepramesh ip (device #3).Should additional information be provided a supplemental emdr will be submitted.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/ davol sepramesh ip and ventralex hernia patch on (b)(6) 2014 and/or (b)(6) 2015 and/or (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against all the devices.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol sepramesh ip and ventralex hernia patch on (b)(6) 2014 and/or (b)(6) 2015 and/or (b)(6) 2017.As reported, the patient is making a claim for an adverse patient outcome against all the devices.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2014 ¿ patient was diagnosed with umbilical hernia thereby underwent open repair with the implant of ventralex mesh (device #1).Per operative notes, ¿a ventralex mesh (device #1) was placed and secured to the fascia using sutures.Postoperatively, patient had peritonitis, small obstruction.¿ (b)(6) 2014 ¿ patient underwent removal of umbilical mesh (device #1).(note: there is no op notes were provided for this procedure in medical record) (b)(6) 2015 ¿ patient was diagnosed with symptomatic ventral hernia thereby underwent open repair with the implant of sepramesh ip (device #2).Per operative notes, ¿there was a large lower midline hernia with adherent small bowel to the underside of the hernia sac within the midline defect.A sepramesh ip (device #2) was placed to defect.¿ (b)(6) 2017 -patient was diagnosed with symptomatic ventral hernia thereby underwent open repair with implant of ventralex mesh.Per op notes, ¿a defect with omentum in midline around prior mediastinal tube sites.A ventralex mesh (device #3) was placed subfascially using sutures.¿.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: this supplemental emdr is submitted to document additional information provided.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 supplemental emdr represents the bard/davol sepramesh ip (device #2).Additional supplemental emdrs were submitted to represent the bard/davol mesh - ventralex (device #1) and bard/davol mesh - ventralex (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.

• 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 ; 4018258495
• MDR Report Key: 10183503
• Report Number: 1213643-2020-06044
• Device Sequence Number: 3016392
• Product Code: FTL
• UDI-Device Identifier: 00801741031830
• UDI-Public: (01)00801741031830(17)170428(10)HUZC1928
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 04/28/2017
• Device Catalogue Number: 5959812
• Device Lot Number: HUZC1928
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 72 YR
• Patient Sex: Male