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

Catalog Number	0112980
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Scar Tissue (2060); Hernia (2240); Insufficient Information (4580)
Date of Event	09/10/2021
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/davol marlex mesh (bard flat mesh) (device #1).An additional emdr was submitted to represent the bard/davol mesh ¿ ventralex (device #2).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.Not returned.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol marlex mesh (bard flat mesh) and ventralex hernia patch on (b)(6) 2007 and/or (b)(6) 2021.As reported, the patient is making a claim for an adverse patient outcome against the both devices.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 unspecified bard/davol marlex mesh (bard flat mesh) and ventralex hernia patch on (b)(6) 2007 and/or (b)(6) 2021.As reported, the patient is making a claim for an adverse patient outcome against the both devices.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) 2007 - patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with implant of perfix plug (device 1 and 2).Per op notes, ¿a direct hernia sac was identified in the right inguinal region and reduced.A perfix plug (device 1) was placed using prolene sutures.A direct hernia sac was identified in the left inguinal region and reduced.A perfix plug (device 2) was placed using prolene sutures.¿ (b)(6) 2021 - patient was diagnosed with incisional hernia in mid abdomen and recurrent right inguinal hernia thereby underwent open repair with implant of ventralex st (device 3) and ventrio st (device 4).Per op notes, ¿incisional hernia sac was identified and reduced.Adhesions were lysed.A ventralex st (device 3) was placed and sutured.A direct hernia sac was identified in the right inguinal region near the prior mesh (device 1) and reduced.Some amount of scar tissue was excised.The peritoneal fat in hernia sac was reduced.A ventrio st (device 4) was placed and sutured.¿.
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 and 510k number.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.Updated fields: a2, b3, b4, b5, b7, d3, d4, d6a, g3, g6, h2, h6, h10, h11.Corrected fields: d1 (brand name), g4 (510k number).This supplemental emdr represents the bard/davol perfix plug (device #1).An additional supplemental emdr was submitted to represent the bard/davol ventralex st (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.H3 other text: not returned.

• Brand Name: PERFIX PLUG
• 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: 15751786
• Report Number: 1213643-2022-097058
• Device Sequence Number: 6321863
• Product Code: FTL
• UDI-Device Identifier: 00801741016684
• UDI-Public: (01)00801741016684(17)110128(10)43JQD173
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: 01/28/2011
• Device Catalogue Number: 0112980
• Device Lot Number: 43JQD173
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2022
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 09/11/2025
• 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: 66 YR
• Patient Sex: Male