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

Catalog Number	5959480
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Fistula (1862); Unspecified Infection (1930)
Date of Event	07/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, no conclusion can be made.As reported, post implant of sepramesh ip, the patient developed small intestinal fistula and abdominal infection and underwent additional surgery.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in november 2022.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
As reported, patient underwent laparoscopic incisional hernia mesh repair with implant of a sepramesh ip.It was reported that post implant, the patient developed small intestinal fistula and abdominal infection and underwent additional surgery.
Additional Manufacturer Narrative
Based on the information provided, no conclusion can be made.As reported, post implant of sepramesh ip, the patient developed small intestinal fistula and abdominal infection and underwent additional surgery.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 96 units released for distribution in (b)(6) 2022.Addendum: this is an addendum to the initial emdr submitted to document the additional information provided.As reported, the mesh was explanted during the revision surgery to treat an intestinal fistula and infection.Fistula formation and infection are known inherent risks of surgery and are listed in the adverse reactions section of the instructions-for-use, supplied with the device as possible complications.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Updated fields: b4, b5, g3, g6, h2, h6, h10 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 : sample not returned.
Event or Problem Description
As reported, patient underwent laparoscopic incisional hernia mesh repair with implant of a sepramesh ip.It was reported that post implant, the patient developed small intestinal fistula and abdominal infection and underwent additional surgery.Addendum: as reported the mesh was removed from the patient's body during the subsequent surgery following implant.The patient is reported to be in good health condition following the second surgery.
Additional Manufacturer Narrative
Based on the information provided, no conclusion can be made.As reported, post implant of sepramesh ip, the patient developed small intestinal fistula and abdominal infection and underwent additional surgery.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in november 2022.Addendum #1: this is an addendum to the initial emdr submitted to document the additional information provided.As reported, the mesh was explanted during the revision surgery to treat an intestinal fistula and infection.Fistula formation and infection are known inherent risks of surgery and are listed in the adverse reactions section of the instructions-for-use, supplied with the device as possible complications.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.Addendum #2: h11: this supplemental mdr is submitted to make corrections and updates.The information provided does not help to determine a cause for the patient¿s postoperative course, no conclusion can be made.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 - mesh explanted.
Event or Problem Description
As reported, patient underwent laparoscopic incisional hernia mesh repair with implant of a sepramesh ip.It was reported that post implant, the patient developed small intestinal fistula and abdominal infection and underwent additional surgery.Addendum: as reported, patient underwent repair using sepramesh ip following diagnosis of intestinal obstruction on (b)(6) 2023.It was reported that the patient underwent a second operation for small bowel fistula (jejunal fistula repair) on (b)(6) 2023 during which the mesh was removed.As reported, the patient is in good health condition after the second operation.

• 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: 17699693
• Report Number: 1213643-2023-00322
• Device Sequence Number: 6719259
• Product Code: FTL
• UDI-Device Identifier: 00801741031816
• UDI-Public: (01)00801741031816
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2023

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: 08/28/2024
• Device Catalogue Number: 5959480
• Device Lot Number: HUGW1552
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 09/11/2023; 10/11/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 09/13/2023; 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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: Unknown