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

Catalog Number	0113710
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Hernia (2240)
Date of Event	04/21/2006
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.This emdr represents the bard pre-shaped 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: (b)(6) 2005 - patient was diagnosed with right inguinal pantaloon slider hernia thereby underwent open repair with implant of perfix plug (device 1) and bard pre-shaped mesh with keyhole (device 2).Per operative notes, "in the right groin area, a huge sac with large deep opening and slider component was taken down and sac was closed with sutures.A medium sized perfix plug (device 1) was placed medial to the cord and transversalis fascia was closed over it.The mesh (device 1) partially closed the internal ring and a large size bard pre-shaped mesh with keyhole (device 2) was placed in position and tacked down to the pubic tubercle, inguinal ligament and rectus fascia.The external oblique was closed over the cord and secured with sutures." (b)(6) 2006 - patient was diagnosed with recurrent right inguinal hernia and pain thereby underwent open repair with implant of ventralex mesh (device 3).Per operative notes, " through the old right groin incision, the hernia was noted.The surface of the cord, hernia were dissected free and direct defect through the internal ring was reduced back through the defect.The old mesh (device 1) was seen drifted medially to uncover this area.Therefore, a ventralex mesh (device 3) was placed in the peritoneum over the defect.The mesh (device 3) was sewn circumferentially with sutures.The cord structures were covered with sutures and staples.".

• Brand Name: BARD MESH PRE-SHAPED W/ KEYHOLE
• 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: 24935994
• Report Number: 1213643-2026-00528
• Device Sequence Number: 5417410
• Product Code: FTL
• UDI-Device Identifier: 00801741030703
• UDI-Public: (01)00801741030703(17)100728(10)43GPD088
• 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: 2005
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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: 07/28/2010
• Device Catalogue Number: 0113710
• Device Lot Number: 43GPD088
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 37 YR
• Patient Sex: Male