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	Adhesion(s) (1695); Pain (1994); Seroma (2069); Hernia (2240); Injury (2348); Disability (2371)
Date of Event	01/11/2010
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.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 mesh (bard flat mesh) and bard/davol ventralight st on (b)(6) 2005 and/or (b)(6) 2011 and/or (b)(6) 2013.As reported, the patient is making a claim for an adverse patient outcome against the bard mesh (bard flat mesh).Attorney alleges that the patient sustained injuries on (b)(6) 2010, (b)(6) 2011 and/or (b)(6) 2013.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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard mesh (bard flat mesh) and bard/davol ventralight st on (b)(6) 2005 and/or (b)(6) 2011 and/or (b)(6) 2013.As reported, the patient is making a claim for an adverse patient outcome against the bard mesh (bard flat mesh).Attorney alleges that the patient sustained injuries on (b)(6) 2010, (b)(6) 2011 and/or (b)(6) 2013.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) 2005 ¿ patient was diagnosed with symptomatic ventral hernia thereby underwent open repair with the implant of bard flat mesh (device 1).Per operative notes, ¿the patient was found to have a large ventral hernia in the lower half of the incision.A bard flat mesh (device 1) was placed on top of the repair and secured using staples.¿ (b)(6) 2010 ¿ patient was diagnosed with large ventral hernia and intraabdominal adhesions thereby underwent laparoscopic repair with the implant of synthetic mesh.Per operative notes, ¿multiple adhesions were taken down.There was a small hernia defect on left side.A synthetic mesh was placed into abdomen using protack staples.¿ (b)(6) 2011 ¿ patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the removal of synthetic mesh and implant of bard flat mesh (device #2).Per operative notes, ¿the previous synthetic mesh was displaced and pulled more to the midline and adhered to small bowel was excised along with protack staples.A piece of bard flat mesh (device #2) was placed on top of repair using sutures.¿ (b)(6) 2013 ¿ patient was diagnosed with recurrent ventral hernia; seroma thereby underwent open repair with the implant of ventralight st (device 3).Per operative notes, ¿a large seroma on top of mesh (device 1 and device 2) was evacuated.The bard flat mesh (device 2) was pulled to the right side leaving a major defect on the left side of the abdomen.The adhesions were released.The hernia sac was found on left side.A ventralight st mesh (device 3) was placed on the defect and anchored to the fascia using sutures.¿.
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.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.Updated fields: a2, b2, b3, b4, b5, b7, d3, d4, 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: not returned.

• 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 ; 4018258495
• MDR Report Key: 11271555
• Report Number: 1213643-2021-00658
• Device Sequence Number: 17014613
• Product Code: FTL
• UDI-Device Identifier: 00801741016523
• UDI-Public: (01)00801741016523(10)43IOD027
• 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: 2005
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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: 0112670
• Device Lot Number: 43IOD027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 91 KG