MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Bard Flat Mesh; Surgical Mesh

Catalog Number	0112670
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Purulent Discharge (1812); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Scar Tissue (2060); Injury (2348); Disability (2371)
Date of Event	05/09/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges injuries; however, no details have been provided.No lot number has been provided; therefore a review of the manufacturing records is not possible.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 an unspecified bard/davol bard mesh on (b)(6) 2010.As reported, the patient is making a claim for an adverse patient outcome against the bard mesh.As reported, the 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." attorney alleges unspecified injuries on (b)(6) 2010.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol bard mesh on (b)(6) 2010.As reported, the patient is making a claim for an adverse patient outcome against the bard mesh.As reported, the 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." attorney alleges unspecified injuries on (b)(6) 2010.Addendum per additional information provided: (b)(6) 2010- patient was diagnosed with ventral hernia thereby underwent open repair with implant of bard flat mesh.Per op notes, ¿the hernia sac with omentum was identified below the umbilicus and the omentum was reduced.The excess hernia sac was dissected.A bard flat mesh was placed in the centre of umbilicus and sutured¿.(b)(6) 2010- patient was diagnosed with necrosis of a portion of abdominal wound, thereby underwent open repair.Per op notes, ¿the necrosis was at the junction of the transverse extended suprapubic incision and the vertical midline incision.Some necrosis under the bard flat mesh was identified.The necrotic tissue were debrided¿.(b)(6) 2010- patient was diagnosed with infected abdominal wall, thereby underwent open repair with debridement of the skin and subcutaneous tissue of abdominal wall defect.(b)(6) 2010- patient was diagnosed with lower abdominal wound, thereby underwent open repair with debridement of the lower abdominal wound.(b)(6) 2010- patient was diagnosed with pain and abdominal wound, thereby underwent open repair with debridement of abdominal wound.(b)(6) 2011- patient was diagnosed with abdominal wall infection, thereby underwent open repair with partial removal of bard flat mesh.Per op notes, ¿the infected bard flat mesh was excised.¿ (b)(6) 2012- patient was diagnosed with infected abdominal wall, thereby underwent open repair with partial explant of bard flat mesh.Per op notes, ¿there was a purulent drainage was noted and a bard flat mesh underneath.The infected part of the mesh was excised.There was a large depressed scar was noted in the midline of abdominal wall¿.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges injuries; however, no details have been provided.No lot number has been provided; therefore a review of the manufacturing records is not possible.Addendum: h11: this supplemental emdr is submitted to document additional information provided and corrected the date of event.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-oct-2009) is considered to be the best estimate.Updated data: a2, b2, b4, b5, b7, d3, d4 (product catalog no, corporate lot no, udi no, expiry date), d6.B (date of explant), g1, g3, g6, h2, h4, h6, h10, h11.Corrected data: b3 (date of event).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: 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 ; +1(401)825-8495
• MDR Report Key: 8759945
• Report Number: 1213643-2019-05781
• Device Sequence Number: 1591251
• Product Code: FTL
• UDI-Device Identifier: 00801741016523
• UDI-Public: (01)00801741016523(17)141028(10)HUTJ0738
• 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: 2010
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2026

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 Expiration Date: 10/28/2014
• Device Catalogue Number: 0112670
• Device Lot Number: HUTJ0738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2009
• 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 Sex: Female