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

Catalog Number	0112700
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240)
Date of Event	03/09/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2015 - patient was diagnosed with right inguinal hernia thereby underwent open repair with the implant of perfix plug (device 1).Per operative notes, ¿an incision was made on the floor of the inguinal canal.Hernia sac was dissected out.A perfix plug (device 1) was placed into the internal ring and secure it with sutures.¿ on (b)(6) 2015 - patient was diagnosed with recurrent right inguinal hernia, adhesion thereby underwent open repair with implant of pre-shaped mesh (device 2).Per operative notes, ¿an incision was made through the old incision.Previously placed perfix plug (device 1) was pulled away from inguinal floor.All adhesions were taken down.Pre-shaped mesh (device 2) was placed into the shelving portion of inguinal ligament and secure it with sutures.¿ on (b)(6) 2016 - patient was diagnosed with recurrent right inguinal hernia, adhesion thereby underwent laparoscopic repair with explant of perfix plug (device 1) and pre-shaped mesh (device 2) and implant of synthetic mesh.Per operative notes, ¿a supraumbilical incision was made.Indirect right inguinal hernia sac was dissected out.Previously placed perfix plug (device 1) and pre-shaped mesh (device 2) were removed.A synthetic mesh was placed in the preperitoneal space and secure it with tackers.¿.
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-feb-2015) is considered to be a best estimate.This emdr represents the bard mesh pre-shaped (device 2).An additional supplemental emdr was submitted to represent the bd 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.

• Brand Name: BARD MESH PRE-SHAPED
• 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: 23439920
• Report Number: 1213643-2025-01050
• Device Sequence Number: 20007408
• Product Code: FTL
• UDI-Device Identifier: 00801741016547
• UDI-Public: (01)00801741016547(17)200128(10)HUZB0511
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K251557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

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: 01/28/2020
• Device Catalogue Number: 0112700
• Device Lot Number: HUZB0511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2015
• 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: 56 YR
• Patient Sex: Female