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

Catalog Number	5959680
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	11/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; 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 #2).Additional emdrs were submitted to represent the bard/davol mesh ¿ composix (device #1) and the bard/davol ventralex st (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 composite mesh (composix) on (b)(6) 2003, sepramesh composite ip on (b)(6) 2011, ventralex st on (b)(6) 2017 and ventralight st on (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against composite mesh (composix), sepramesh composite ip and ventralex st.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; 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 #2).Additional emdrs were submitted to represent the bard/davol mesh ¿ composix (device #1) and the bard/davol ventralex st (device #3).Should additional information be provided, a supplemental emdr will be submitted.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-dec-2010) 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 ¿ composix (device #1) and the bard/davol 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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol composite mesh (composix) on (b)(6) 2003, sepramesh composite ip on (b)(6) 2011, ventralex st on (b)(6) 2017 and ventralight st on (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against composite mesh (composix), sepramesh composite ip and ventralex st.Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2003 - patient was diagnosed with reducible abdominal incisional hernia thereby underwent open repair with the implant of composix mesh (device #1).Per operative notes, ¿a composix mesh (device #1) was placed and sutured.¿ (b)(6) 2011 - patient was diagnosed with recurrent incarcerated abdominal incisional hernia, adhesion thereby underwent laparoscopic repair with the explant of rolled composix mesh (device #1) and implant of sepramesh ip (device #2).Per operative notes, ¿composix mesh (device #1) was removed.Sepramesh ip (device #2) was placed and sutured.¿ (b)(6) 2017 - patient was diagnosed with recurrent reducible abdominal incisional hernia, adhesion thereby underwent laparoscopic repair with the implant of the ventralex st mesh (device #3).Per operative notes, ¿a ventralex st mesh (device #3) was placed and sutured.¿ (b)(6) 2020 - patient was diagnosed with reducible recurrent incisional hernia, adhesion thereby underwent laparoscopic repair with the explant of ventralex st mesh (device #3) and implant of the ventralight st mesh (device #4).Per operative notes, ¿ventralex st mesh (device #3) was removed.Ventralight st mesh (device #4) was placed and sutured.¿.

• 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: 11086050
• Report Number: 1213643-2020-11481
• Device Sequence Number: 7803679
• Product Code: FTL
• UDI-Device Identifier: 00801741031823
• UDI-Public: (01)00801741031823(17)121228(10)HUUL0993
• 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: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: 12/28/2012
• Device Catalogue Number: 5959680
• Device Lot Number: HUUL0993
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2010
• 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: Disability; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male