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	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Pain (1994)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient is experiencing abdominal pain, joint pain, increased back pain and also has occasional redness at the mesh site and face post implant of sepramesh ip.A mesh sample has been provided for reactivity testing.At this time the testing has not been scheduled.No conclusions can be made at this time.If/when reactivity test results are provided, a supplemental mdr will be submitted.The adverse reactions section of the instructions-for-use supplied with the device lists allergic reaction, pain and erythema as possible complications.No lot number has been provided; therefore, a review of the manufacturing records is not possible.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, the patient underwent a hybrid repair of ventral wall abdominal hernia, umbilical hernia with implant of a sepramesh ip mesh and a right salpingo oophorectomy performed on (b)(6) 2022.Complainant reports that the patient has been experiencing abdominal pain, joint pain, and increased back pain since she had her hernia repair in 2022.The patient also felt occasional redness at the mesh site and face.Patient attributes symptoms to mesh and would like to have allergy testing performed.Patient has not had any treatments provided at this time.
Event or Problem Description
As reported, the patient underwent a hybrid repair of ventral wall abdominal hernia, umbilical hernia with implant of a sepramesh ip mesh and a right salpingo oophorectomy performed on (b)(6) 2022.Complainant reports that the patient has been experiencing abdominal pain, joint pain, and increased back pain since she had her hernia repair in 2022.The patient also felt occasional redness at the mesh site and face.Patient attributes symptoms to mesh and would like to have allergy testing performed.Patient has not had any treatments provided at this time.Addendum: reactivity testing has been performed and as reported the results were negative for an allergic response to the mesh sample.
Additional Manufacturer Narrative
As reported, the patient is experiencing abdominal pain, joint pain, increased back pain and also has occasional redness at the mesh site and face post implant of sepramesh ip.A mesh sample has been provided for reactivity testing.At this time the testing has not been scheduled.No conclusions can be made at this time.If/when reactivity test results are provided, a supplemental mdr will be submitted.The adverse reactions section of the instructions-for-use supplied with the device lists allergic reaction, pain and erythema as possible complications.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: this is an addendum to the previously submitted mdr to document reactivity test results.Reactivity testing has been performed and as reported the results were negative for an allergic response to the mesh sample.It is unknown at this time, what is causing the patient's condition.However, based on testing performed the postoperative symptoms experienced by the patient do not appear to be caused by the sepramesh ip, used to treat the patient.Updated fields: b4, b5 (event description), b6 (relevant tests and lab data), 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.

• 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: 24593794
• Report Number: 1213643-2026-00333
• Device Sequence Number: 10391335
• Product Code: FTL
• UDI-Device Identifier: 00801741031816
• UDI-Public: (01)00801741031816
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Age: 60 YR
• Patient Sex: Female