MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD FLAT MESH; SURGICAL MESH

Catalog Number	0112650
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Impaired Healing (2378); Fibrosis (3167)
Date of Event	08/24/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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-jun-2008) is considered to be a best estimate.This emdr represent the bard flat mesh (device #2).An additional supplemental emdr was submitted to represents the bard flat mesh (device #1).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
Per information provided: on (b)(6) 2008 - patient was diagnosed with ventral incisional hernia thereby underwent open repair with the implant of bard flat mesh (device #1).Per operative notes, ¿the hernia sac was dissected.A bard flat mesh (device #1) was placed and secure it with suture.¿ on (b)(6) 2009 - patient was diagnosed with very large right indirect inguinal hernia thereby underwent open repair with implant of bard flat mesh (device #2).Per operative notes, ¿a large bulge was beneath the abdominal wall.The huge hernia sac was then dissected.A bard flat mesh (device #2) was placed and secure it with suture.¿ on (b)(6) 2011 - patient was diagnosed with chronic infected mesh thereby underwent open repair with the explant of bard flat mesh (device #2).Per operative notes, ¿histiocytic inflammation and aponeurosis was there.A transverse incision was made.The infected bard flat mesh (device #2) was then dissected.¿ on (b)(6) 2012 - patient was diagnosed with nonhealing abdominal wound thereby underwent open repair with explant of the bard flat mesh (device #1).Per operative notes, ¿bard flat mesh (device #1) and the sutures were excised from the wound.The wound was thoroughly irrigated.¿.

• 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: 21949403
• Report Number: 1213643-2025-090187
• Device Sequence Number: 8800435
• Product Code: FTL
• UDI-Device Identifier: 00801741016509
• UDI-Public: (01)00801741016509(17)130728(10)HUSF1184
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2025

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: 07/28/2013
• Device Catalogue Number: 0112650
• Device Lot Number: HUSF1184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2008
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 70 KG