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

Catalog Number	0112710
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Nerve Damage (1979); Pain (1994)
Date of Event	05/23/2011
Type of Reportable Event	Serious Injury
Event or Problem Description
Per information provided: on (b)(6) 2005 - patient was diagnosed bilateral inguinal hernias thereby underwent open repair with the implant of bard mesh pre-shaped with keyhole (device #1, #2).Per operative notes, "on right side, a direct hernia was noted and a bard mesh pre-shaped with keyhole (device #1) was sutured.On right side, a large direct hernia.A bard mesh pre-shaped with keyhole (device #2) was placed and sutured." on (b)(6) 2011 - patient was diagnosed with bilateral groin pain thereby underwent laparoscopic repair with the removal of meshes (device #1, #2) and implant of bard soft mesh (device #3, #4).Per operative notes, "on right side, a bard soft mesh (device #3) and tacked.Same procedure was done on the left side with bard soft mesh (device #4) tacked in midline.The mesh was densely adherent to the nerves.The ilioinguinal, genitofemoral nerves were resected.The mesh (device #1, #2) was removed.".
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 mesh pre-shaped w/ keyhole (device #2).An additional supplemental emdr was submitted to represent the bard mesh pre-shaped w/ keyhole (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 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: 22163691
• Report Number: 1213643-2025-00441
• Device Sequence Number: 7369444
• Product Code: FTL
• UDI-Device Identifier: 00801741016554
• UDI-Public: (01)00801741016554(10)43DMD062
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2025

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 Catalogue Number: 0112710
• Device Lot Number: 43DMD062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 06/07/2025
• 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: Disability; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male