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

Catalog Number	0117011
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	11/12/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: (b)(6) 2010 ¿ patient was diagnosed with reducible right inguinal hernia thereby underwent open repair with the implant of bard preshaped mesh (device #1).Per op notes, ¿a large indirect hernia along the spermatic cord was noted.A onlay bard preshaped mesh (device #1) was placed into defect and sutured with a pubic tubercle.¿ (b)(6) 2011 ¿ patient was diagnosed with recurrent symptomatic right inguinal hernia thereby underwent laparoscopic repair with the implant of bard soft mesh (device #2).Per op notes, ¿small indirect sac was adherent to the spermatic cord.A sheet of bard soft mesh (device #2) was placed to cover the defect in inguinal floor and secured to the periosteum adjacent to the pubis and right cooper ligament using tacks.¿ (b)(6) 2014 ¿ patient was diagnosed with recurrent right inguinal hernia thereby underwent robotic repair with the removal of mesh (device #1, #2).Per op notes, ¿there were some adhesions in the right lower quadrant.In the middle portion, there was an intense inflammatory reaction.The previously placed mesh (device #1, #2) had contracted and formed a ball was freed off the spermatic cord and excised.A synthetic mesh was placed into defect and sutured.¿.
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.This emdr was submitted to represent the bard soft mesh (device #2).An additional supplemental emdr was submitted to represent the bard mesh pre-shaped (device #1).Note, the manufacturing date (15-oct-2010) is considered to be a best estimate.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 SOFT 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: 22313255
• Report Number: 1213643-2025-00515
• Device Sequence Number: 9023422
• Product Code: FTL
• UDI-Device Identifier: 00801741030888
• UDI-Public: (01)00801741030888(17)151028(10)HUUJ0460
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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: 10/28/2015
• Device Catalogue Number: 0117011
• Device Lot Number: HUUJ0460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2010
• 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: 47 YR
• Patient Sex: Male
• Patient Weight: 98 KG