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	Pain (1994); Injury (2348); Disability (2371)
Date of Event	01/21/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges surgical intervention 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 patient"; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard flat mesh (device #2).Additional emdrs were submitted to represent the bard flat mesh (device #1) and bard/davol mesh ¿ composix (device # 3).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 two unspecified bard meshes (bard flat mesh) on (b)(6) 2000, (b)(6) 2002 and a bard/davol composite mesh (composix) on (b)(6) 2006.As reported, the patient is making a claim for an adverse patient outcome against all devices.It is alleged that the patient had revision surgeries on (b)(6) 2013 and (b)(6) 2018 due to the defect in the bard mesh.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 injuries sustained by the patient." it is also alleged that the patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges surgical intervention 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 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, b3, b4, b5, b7, d4 (product catalog no., corporate lot no, udi no.), g3, g6, h2, h6, h10.This supplemental emdr represents the bard/davol - bard flat mesh (device 2).Additional supplemental emdr's were submitted to represent the bard/davol -bard flat mesh (device 1), composix mesh (device 3).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 two unspecified bard meshes (bard flat mesh) on (b)(6) 2000, (b)(6) 2002 and a bard/davol composite mesh (composix) on (b)(6) 2006.As reported, the patient is making a claim for an adverse patient outcome against all devices.It is alleged that the patient had revision surgeries on (b)(6) 2013 and (b)(6) 2018 due to the defect in the bard mesh.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 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) 2000 - patient was diagnosed with ventral hernia thereby underwent open repair with implant of bard flat mesh (device 1).Per op notes, ¿a large hernia defect was identified and reduced.A bard flat mesh (device 1) was placed and sutured.¿ (b)(6) 2002 - patient was diagnosed with right inguinal hernia thereby underwent open repair with implant of bard flat mesh (device 2).Per op notes, ¿a large indirect hernia sac was identified and reduced.Cord lipoma was excised.A bard flat mesh (device 2) was placed and sutured.¿ (b)(6) 2006 - patient was diagnosed with incarcerated recurrent ventral incisional hernia thereby underwent open repair with implant of composix mesh (device 3).Per op notes, ¿the prior mesh (device 1) was noted.Two large hernia defects on the left side of prior mesh (device 1).The hernia sac was reduced.A composix mesh (device 3) was placed using prolene sutures.¿ (b)(6) 2013 - patient was diagnosed with small bowel obstruction thereby underwent open repair.Per op notes, ¿the prior meshes (device 1 and 2) were noted.Adhesions of mesh and abdominal wall were lysed.The small bowel obstruction was released and sutured.¿ (b)(6) 2018 - patient was diagnosed with adhesions, cholelithiasis, appendicitis and recurrent ventral incisional hernia thereby underwent open repair with adhesiolysis.Per op notes, ¿the hernia sac was identified and opened.Multiple adhesions of abdominal wall were lysed.The loops of small bowel adherent to prior mesh (device 1 and 2) were taken down.Cholecystectomy and appendectomy were performed.The defect was repaired with sutures.¿.

• 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: 9780670
• Report Number: 1213643-2020-01920
• Device Sequence Number: 2649863
• Product Code: FTL
• UDI-Device Identifier: 00801741016523
• UDI-Public: (01)00801741016523(10)43DLD116
• 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: 2002
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: 43DLD116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 09/04/2025
• 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: 49 YR
• Patient Sex: Male