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

Catalog Number	0112640
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240)
Date of Event	04/28/2015
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-aug-2008) is considered to be a best estimate.This emdr represents the bard flat mesh (device 2).An additional supplemental emdr was submitted to represent the bard perfix plug (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) 2009 - patient was diagnosed with bilateral inguinal hernia thereby underwent open repair with implant of perfix plug (device 1) and bard flat mesh (device 2).Per op notes, "a very large lipoma of the cord was identified in the left and dissected free and continued up to the internal ring.A perfix plug (device 1) was placed and secured with suture.A smaller lipoma was identified in the right side and separated from the cord structures and dissected to the internal ring.A bard flat mesh (device 2) was placed and secured with suture." on (b)(6) 2015 - patient was diagnosed with bilateral recurrent hernias thereby underwent laparoscopic repair with implant of 3dmax mesh (device 3 and 4).Per op notes, "an infraumbilical incision was made.A small umbilical fascial defect was noted.A recurrent direct left inguinal hernia with a visible mesh (device 1) was noted.A recurrent indirect inguinal hernia was identified at the right inguinal region.A dense adherence of the spermatic cord and vas deferens to the mesh (device 2) in the right inguinal region was noted.A 3dmax mesh (device 3) was placed in the right and 3dmax mesh (device 4) was placed in the left and secured with staples.".

• 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: 25299805
• Report Number: 1213643-2026-00679
• Device Sequence Number: 21174206
• Product Code: FTL
• UDI-Device Identifier: 00801741016493
• UDI-Public: (01)00801741016493(17)130928(10)HUSH0135
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2013
• Device Catalogue Number: 0112640
• Device Lot Number: HUSH0135
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2008
• 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: 62 YR
• Patient Sex: Male