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

Catalog Number	0112660
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Material Deformation (2976)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Bowel Perforation (2668); Insufficient Information (4580)
Date of Event	03/06/2025
Type of Reportable Event	Death
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard flat mesh on (b)(6) 2001.As reported, the patient is making a claim for an adverse patient outcome against the bard flat mesh.Attorney alleges wrongful death of the patient and 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 adverse patient outcome associated with the hernia mesh used to treat the patient including death and "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 plaintiff.No medical records, autopsy report, or death certificate have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event (06-mar-2025) and date of death (b)(6)2025) considered to be a best estimate.Should additional information be provided, a supplemental emdr will be submitted.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.
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 including death and "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 plaintiff.No medical records, autopsy report, or death certificate have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of event (06-mar-2025) and date of death (01-jan-2025) considered to be a best estimate.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the gender.Based on the information received, post implant of bard flat mesh, attorney alleges that the patient had perforation, nerve damage, infection, fistula, obstruction, hernia recurrence, adhesions, seroma, pain and mesh shrinkage.Per previous legal claim and ppf, it was mentioned that patient passed away.No information regarding patient¿s death in the medical records provided to date and no autopsy report, or death certificate have been provided.Summary will be updated if/when additional information is received.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 an unspecified bard flat mesh on (b)(6) 2001.As reported, the patient is making a claim for an adverse patient outcome against the bard flat mesh.Attorney alleges wrongful death of the patient and 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) 2001 - patient was diagnosed with incisional hernia and small bowel obstruction thereby underwent open repair with implant of bard flat mesh.Per op notes, ¿the hernia sac was noted with incarcerated small bowel was reduced.Adhesions were lysed.The hernia sac was excised.A bard flat mesh was placed and sutured.¿ (b)(6) 2008 to (b)(6) 2018 ¿ patient had pain and depression.Attorney alleges death, perforation, nerve damage, infection, fistula, obstruction, hernia recurrence, adhesions, seroma, pain and mesh shrinkage.

• Brand Name: BARD FLAT MESH
• 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: 21718126
• Report Number: 1213643-2025-00246
• Device Sequence Number: 18419215
• Product Code: FTL
• UDI-Device Identifier: 00801741016516
• UDI-Public: (01)00801741016516(10)43CKD140
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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 Catalogue Number: 0112660
• Device Lot Number: 43CKD140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 11/21/2025
• 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: Life Threatening; Disability; Death
• Patient Sex: Female