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

Catalog Number	5959360
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Injury (2348)
Date of Event	05/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.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 (device #2) and bard/davol ventralex (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, ventralex hernia patch (x2) and ventralight st on (b)(6) 2008 and/or (b)(6) 2015 and/or (b)(6) 2018.As reported, the patient is making a claim for an adverse patient outcome against the sepramesh ip and ventralex hernia patch (x2).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, ventralex hernia patch (x2) and ventralight st on (b)(6) 2008 and/or (b)(6) 2015 and/or (b)(6) 2018.As reported, the patient is making a claim for an adverse patient outcome against the sepramesh ip and ventralex hernia patch (x2).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) 2008 ¿ patient was diagnosed with umbilical hernia and incisional hernia thereby underwent open repair with implant of two ventralex mesh (device #1 and #2).Per operative notes, ¿the incisional hernia was identified and sac was dissected.A small ventralex mesh (device #1) was placed.The umbilical hernia was noted in the midline and sac was dissected.A medium ventralex mesh (device #2) was placed and secured with sutures and tacks.¿ (b)(6) 2011 ¿ patient underwent bilateral partial salpingectomy during which umbilical mesh (device #2) was noted.The mesh and fascia was closed with sutures.¿ (b)(6) 2011 ¿ patient was diagnosed with recurrent incisional/umbilical hernia thereby underwent open repair.Per operative notes, ¿a medium ventralex mesh (device #2) was noted.The mesh (device #2) did not attach well to the fascia and flipped inferiorly.The mesh was then placed in expected position and sutured to anterior rectus sheath.¿ (b)(6) 2015 ¿ patient was diagnosed with recurrent supraumbilical ventral hernia and displaced mesh thereby underwent laparoscopic repair with removal of mesh (device #2) and implant of sepramesh ip mesh (device #3).Per operative notes, ¿omental adhesions were taken down and previously placed mesh was covered up and appeared like a ball.The mesh (device #2) was excised completely.The recurrent defect was repaired with sepramesh ip (device #3) and sutured in corners.¿ (b)(6) 2018 ¿ patient was diagnosed with recurrent incisional hernia thereby underwent robotic combined with open repair with removal of ventralex mesh (device #1) and sepramesh ip (device #3) and implant of ventralight st using echo ps (device #4).Per operative notes, ¿numerous adhesions were removed.In left side, a defect and mesh (device #1) was seen rolled around.A large previously placed mesh (device #3) was noted, these meshes (device #1 and #3) were completely removed and fascia was closed with sutures.A ventralight st using echo ps (device #4) was placed around the fascial defect sutured and tacked.¿.
Additional Manufacturer Narrative
At this time no conclusions can be made.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-aug-2013) is considered to be a best estimate.This supplemental emdr represents the sepramesh ip (device #3).An additional supplemental emdr was submitted to represent the bard/davol mesh -ventralex (device #1, #2).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: 10012823
• Report Number: 1213643-2020-04244
• Device Sequence Number: 2968026
• Product Code: FTL
• UDI-Device Identifier: 00801741031809
• UDI-Public: (01)00801741031809(17)150828(10)HUXH1301
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: 08/28/2015
• Device Catalogue Number: 5959360
• Device Lot Number: HUXH1301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2013
• 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: 35 YR
• Patient Sex: Female