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	Hernia (2240); Injury (2348)
Date of Event	06/05/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol may have caused or contributed to the reported event.The attorney alleges that the patient had subsequent surgical intervention;however no details have been provided.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.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) 2013.As reported, the patient is making a claim for an adverse patient outcome against the bard/davol bard mesh.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the attorney alleges patient experienced emotional distress and the device was defective.
Additional Manufacturer Narrative
At this time no conclusions can be made to what extent the bard/davol may have caused or contributed to the reported event.The attorney alleges that the patient had subsequent surgical intervention;however no details have been provided.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.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.Note, the manufacturing date (15-dec-2012) is considered to be a best estimate.Updated fields: a2, b3, b4, b5, b6, b7, d4 (product catalog no., corporate lot no, expiry date, udi no.), g3, g6, h2, h4, 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.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol bard mesh on (b)(6) 2013.As reported, the patient is making a claim for an adverse patient outcome against the bard/davol bard mesh.It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device.As reported, the attorney alleges patient experienced emotional distress and the device was defective.Addendum per additional information provided: on (b)(6) 2013 ¿ patient was diagnosed with left direct inguinal hernia thereby underwent open repair with implant of bard flat mesh (device #1).Per operative notes, ¿ there is no any evidence of a sac, the mild weakness in the floor of the inguinal canal was noted.A bard flat mesh (device #1) was placed and secured medially with sutures.¿ on (b)(6) 2015 - patient was diagnosed with symptomatic left recurrent inguinal hernia thereby underwent laparoscopic repair with implant of bard soft mesh (device #2).Per operative notes, ¿ there is no direct hernia noted, the indirect hernia sac was dissected away from the cord structures and then reduced.A bard soft mesh (device # 2) was placed in the floor of the inguinal area and tacked.¿.

• 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: 8852042
• Report Number: 1213643-2019-06550
• Device Sequence Number: 259825
• Product Code: FTL
• UDI-Device Identifier: 00801741016523
• UDI-Public: (01)00801741016523(17)180128(10)HUWL1294
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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: 01/28/2018
• Device Catalogue Number: 0112670
• Device Lot Number: HUWL1294
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2012
• 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: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male