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

Catalog Number	0112660
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Granuloma (1876); Pain (1994)
Date of Event	08/27/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2006 - patient was diagnosed with multiple incisional hernia of old midline incision thereby underwent laparoscopic repair with the implant of bard flat mesh (device #1).Per operative notes, ¿a bard flat mesh (device #1) was placed and sutured.¿ (b)(6) 2011 - patient was diagnosed with incisional ventral wall hernia, adhesion thereby underwent open repair with the implant of bard flat mesh (device #2).Per operative notes, ¿one bard flat mesh (device #2) was placed and sutured.¿ (b)(6) 2011 - patient was diagnosed with infected abdominal wall mesh post ventral hernia repair, seroma, pain thereby underwent open repair with exploration of abdominal wall wound, drainage of subfascial seroma.Per operative notes, ¿old mesh was not removed.¿ (b)(6) 2011 - patient was diagnosed with ventral hernia thereby underwent open repair with the implant of bard flat mesh (device #3).Per operative notes, ¿one bard flat mesh (device #3) was placed and sutured.¿ (b)(6) 2012 - patient was diagnosed with persistent pain status post ventral hernia repair, suspected suture granuloma thereby underwent open repair with removal of several suture granuloma.
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-aug-2010) is considered to be a best estimate.This emdr represents the bard flat mesh (device #3).Additional supplemental emdr's were submitted to represent the bard flat mesh (device #1 and 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.

• 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 ; 8005566756
• MDR Report Key: 22217701
• Report Number: 1213643-2025-00489
• Device Sequence Number: 8619531
• Product Code: FTL
• UDI-Device Identifier: 00801741016516
• UDI-Public: (01)00801741016516(17)150828(10)HUUH1650
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2025

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: 08/28/2015
• Device Catalogue Number: 0112660
• Device Lot Number: HUUH1650
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2010
• 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: 48 YR
• Patient Sex: Male