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

Catalog Number	0117011
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Hernia (2240)
Date of Event	09/30/2015
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-sep-2009) is considered to be a best estimate.This mdr represents the bard soft mesh (device 1).An additional supplemental emdr was submitted to represent the perfix plug (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.
Event or Problem Description
Per information provided: (b)(6) 2010 - patient was diagnosed with left inguinal hernia thereby underwent laparoscopic repair with implant of bard soft mesh (device 1).Per op notes, ¿a large indirect hernia with cord lipoma was identified and reduced.The hernia sac was dissected off.A bard soft mesh (device 1) was placed and tacked to coopers ligament.¿ (b)(6) 2011 - patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with implant of perfix plug (device 2).Per op notes, ¿a large indirect hernia sac was identified and opened.Some omentum and small bowel were reduced and transected.A large perfix plug (device 2) was placed and sutured to pubic tubercle.¿ (b)(6) 2015 - patient was diagnosed with recurrent left inguinal hernia with pain thereby underwent open repair with excision of bard soft mesh (device 1), perfix plug (device 2) and implant of synthetic mesh.Per op notes, ¿extensive scarring was noted in external oblique.Adhesions were lysed.The cord was dissected from the old meshes (device 1 and 2).Vas deference was adherent to old mesh taken down.The laparoscopically placed old mesh (device 1) was bulging and protruding through the floor of inguinal canal.The previous open repair old mesh (device 2) was completely bunched up and scrambled up.All the meshes (device 1 and 2) were excised entirely.The hernia was identified and reduced.A synthetic mesh was placed and sutured to coopers ligament.¿.

• 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: 23942384
• Report Number: 1213643-2025-01298
• Device Sequence Number: 10758106
• Product Code: FTL
• UDI-Device Identifier: 00801741030888
• UDI-Public: (01)00801741030888(17)140928(10)HUTI0948
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

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: 09/28/2014
• Device Catalogue Number: 0117011
• Device Lot Number: HUTI0948
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2009
• 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: 63 YR
• Patient Sex: Male