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

Catalog Number	0112950
Medical Device Problem Codes	Defective Device (2588); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
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 perfix plug (device #2).An additional emdr was submitted to represent the bard/davol 3dmax (device #1).Should additional information be provided, a supplemental emdr will be submitted.
Event or Problem Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol 3dmax mesh, perfix plug and ventralight st on (b)(6) 2012 and/or (b)(6) 2013.As reported, the patient is making a claim for an adverse patient outcome against the 3dmax mesh and perfix plug.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 3dmax mesh, perfix plug and ventralight st on (b)(6) 2012 and/or (b)(6) 2013.As reported, the patient is making a claim for an adverse patient outcome against the 3dmax mesh and perfix plug.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) 2012 ¿ patient was diagnosed with right inguinal hernia thereby underwent laparoscopic repair with implant of 3dmax mesh (device #1).Per operative notes, ¿indirect inguinal hernia sac was dissected and large size 3dmax mesh (device #1) was placed and tacked and sutured.¿ (b)(6) 2013 ¿ patient was diagnosed with recurrent right inguinal hernia and left inguinal hernia and umbilical hernia thereby underwent laparoscopic and open repair with implant of ventralight st mesh (device #2) and two perfix plug (device #3 and #4).Per operative notes, ¿in left upper quadrant, a umbilical hernia defect was noted and placed with 3dmax mesh (device#2).In the left lower quadrant, medial defect in the cord was noted and perfix plug (device #3) was placed and sutured.In the right-side lower quadrant,¿ a large amount of scarring with direct hernia was noted.A perfix plug (device #4) was placed and sutured and tacked.¿ (b)(6) 2021 ¿ patient had adhesions, abdominal pain thereby underwent laparoscopic repair thereby underwent lysis of adhesions.Per operative notes, ¿omental adhesions were taken down, the mesh (device #2) was seen depressed in the centre 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: this supplemental emdr is submitted to document additional information provided.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-2013) is considered to be a best estimate.This supplemental emdr represents the bard/davol perfix plug (device #4).An additional supplemental emdr and an emdr were submitted to represent the bard/davol 3dmax (device #1) and bard/davol ventralight st (device #2).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: 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: 11905847
• Report Number: 1213643-2021-04009
• Device Sequence Number: 1310271
• Product Code: FTL
• UDI-Device Identifier: 00801741016653
• UDI-Public: (01)00801741016653(17)180228(10)HUXB1585
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2025

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: 02/28/2018
• Device Catalogue Number: 0112950
• Device Lot Number: HUXB1585
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 05/30/2021
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2013
• 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 Sex: Male