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

Catalog Number	0112670
Medical Device Problem Codes	Defective Device (2588); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240); Injury (2348); Disability (2371); Obstruction/Occlusion (2422)
Date of Event	02/20/2009
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol flat mesh(device #1) may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol flat mesh (device #1).An additional emdr was submitted to represent the bard/davol flat mesh (device #2).Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol bard mesh (device #1 and device #2) on (b)(6) 2007 and (b)(6) 2008.As reported, the patient is making a claim for an adverse patient outcome against the two (2) bard mesh(device #1 and device #2).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.".
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol flat mesh (device #1) may have caused or contributed to the reported event.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard/davol flat mesh (device #1).An additional emdr was submitted to represent the bard/davol flat mesh (device #2).Addendum: this supplemental emdr is submitted to document additional information provided.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 2 post implant of bard flat mesh, patient was diagnosed with hernia recurrence, adhesions and obstruction thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device lists hernia recurrence and adhesions as possible complications.This supplemental emdr represents the bard flat mesh (device #1).An additional supplemental emdr was submitted to represent the bard flat mesh (device #2).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/davol bard mesh (device #1 and device #2) on (b)(6)2007 and (b)(6)2008.As reported, the patient is making a claim for an adverse patient outcome against the two (2) bard mesh (device #1 and device #2).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." addendum per additional information provided: (b)(6)2007 - patient was diagnosed with painful scar, protuberance and hernia in epigastric region thereby underwent repair with implant of bard mesh (device #1).Per operative notes, ¿a small epigastric hernia was repaired with bard mesh (device #1) and sutured in place.¿ (b)(6)2007 - patient had small bowel obstruction thereby underwent repair.Per operative notes, ¿the site of obstruction found in left mid abdomen.The adhesions were lysed and dense scar encountered.Many small defects in abdominal wall incorporated into a closure.¿ (note, no mesh was visualized during this repair).(b)(6)2008 - patient had abdominal wall hernia thereby underwent repair with bard mesh (device #2).Per operative notes, ¿the hernia sac was dissected away from defect.In the anterior abdominal wall, there was bilobed hernia defect.A piece of bard mesh (device #2) used to cover both defects and helical tacked to the wall.The mesh was cut to appropriate size then sutured in placed.¿ (note, the mesh (device #1) was not visualized during this repair).(b)(6)2008 - patient had laxity of mesh abdominal wall incisional hernia thereby underwent repair.Per operative notes, ¿noted a protuberance of left lower repair of hernia repair consisted with a separation of mesh (device #2) from fascia.The mesh was tightened by placing additional sutures.¿ (b)(6)2008 - patient had recurrent abdominal hernia thereby underwent repair.Per operative notes, ¿the hernia defect was noted to be due to prior placed mesh (device #2) separating from right lateral aspect of abdominal wound which was adherent on opposite side.Sutures were used to reattach the mesh circumferentially.¿ (b)(6)2009 - patient had recurrent incisional hernia thereby underwent lap converted to open repair with mesh and removal of old mesh.Per operative notes, ¿small bowel dense adhesions to the mesh were lysed.Excised all mesh (device #1 & #2) completely.There was some omentum that adherent to bowel causing an internal hernia.A synthetic (vicryl) mesh was used to repair the defect and sutured in place.¿ attorney alleges that the patient had adhesions, bowel obstruction, bowel perforation, mesh migration, pain and hernia recurrence.

• Brand Name: BARD FLAT MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: 8894540
• Report Number: 1213643-2019-07073
• Device Sequence Number: 1401056
• Product Code: FTL
• UDI-Device Identifier: 00801741016523
• UDI-Public: (01)00801741016523(17)110828(10)43IQD254
• 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: 2007
• Device Explanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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 Expiration Date: 08/28/2011
• Device Catalogue Number: 0112670
• Device Lot Number: 43IQD254
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 03/25/2025
• 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: 52 YR
• Patient Sex: Male