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 Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Hernia (2240); Insufficient Information (4580)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.This emdr represents the bard mesh (bard flat mesh).An additional emdr was submitted to represent the bard mesh (bard flat mesh).Should additional information be provided, a supplemental emdr will be submitted.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
Attorney alleges that the patient underwent surgery for implant of an unspecified bard mesh (bard flat mesh) (x3) on (b)(6) 2000 (x2) and (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against bard mesh (bard flat mesh) (x2).Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard mesh (bard flat mesh) (x3) on (b)(6) 2000 (x2) and (b)(6) 2020.As reported, the patient is making a claim for an adverse patient outcome against bard mesh (bard flat mesh) (x2).Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided: (b)(6) 2000 - patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with implant of bard pre-shaped mesh with keyhole (device 1 and 2).Per op notes, ¿a direct hernia sac was noted on right inguinal region and dissected away.A bard pre-shaped mesh with keyhole (device 1) was placed on right side and stapled.A large direct hernia sac was noted on left inguinal region and dissected away.A bard mesh pre-shaped with keyhole (device 2) was placed on left side and stapled.¿ (b)(6) 2020 - patient was diagnosed with incarcerated recurrent right inguinal hernia with pain thereby underwent open repair with partial excision of bard pre-shaped mesh with keyhole (device 1) and implant of bard flat mesh (device 3).Per op notes, ¿multiple adhesions from prior repair were taken down.Scar tissues were excised.Pieces of prior mesh (device 1) with staples were noted and excised.The indirect hernia sac was noted and excised.A bard flat mesh (device 3) was placed and sutured medially to the pubic tubercle.¿ (b)(6) 2020 - patient was diagnosed with recurrent right inguinal hernia thereby underwent robotic assisted laparoscopic repair with implant of synthetic mesh.Per op notes, ¿a large direct hernia sac was noted and reduced.A synthetic mesh was placed and sutured.¿ (note: the prior meshes (device 3) are not visualized during this procedure).
Additional Manufacturer Narrative
No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: h11: this supplemental emdr is submitted to document additional information provided and to correct the brand name.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 supplemental emdr represents the bard pre-shaped mesh with keyhole (device 1).Additional supplemental emdr and an emdr were submitted to represent the bard pre-shaped mesh with keyhole (device 2) and bard flat mesh (device 3).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 ; 4018258495
• MDR Report Key: 12934259
• Report Number: 1213643-2021-09068
• Device Sequence Number: 14691837
• Product Code: FTL
• UDI-Device Identifier: 00801741016554
• UDI-Public: (01)00801741016554(10)43DKD094
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 43DKD094
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 99 KG