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

Catalog Number	0112960
Medical Device Problem Codes	Defective Device (2588); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hernia (2240); Insufficient Information (4580)
Date of Event	05/08/2019
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.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 an unspecified bard/davol perfix plug on (b)(6) 2010.As reported, the patient is making a claim for an adverse patient outcome against the 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 an unspecified bard/davol perfix plug on (b)(6) 2010.As reported, the patient is making a claim for an adverse patient outcome against the 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) 2010 - patient was diagnosed with ventral incisional hernia thereby underwent laparoscopic repair with the implant of perfix plug (device #1 and device #2).Per operative notes, ¿the peritoneum was dissected from the surrounding soft tissue.A medium sized mesh plug (device #1) was placed and sutured to the transversalis fascia using sutures.Then a defect in the linea alba was closed by small mesh plug (device #2).¿ (b)(6) 2019 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent laparoscopic to open repair with removal of perfix plug (device #1) and implant of bard flat mesh (device #3).Per operative notes,"omentum stuck in left lower quadrant hernia was noted.The entire mesh was removed (device #1).A bard flat mesh (device #3) was placed in the subfascial space and secured by sutures.Previously placed mesh (device #2) had appeared to be holding well and preventing a hernia.¿ attorney alleged that the patient had adhesions, pain and hernia recurrence.
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.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 9 years post implant of perfix plug, patient was diagnosed with hernia recurrence thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device list hernia recurrence as possible complication.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.
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 #1: this supplemental emdr is submitted to document additional information.Based on the additional information received, there is no change to initial determination, no conclusions can be made.Per medical records review, about 9 years post implant of perfix plug, patient was diagnosed with hernia recurrence thereby underwent repair with removal of mesh.The instructions-for-use supplied with the device list hernia recurrence as possible complication.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
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol perfix plug on (b)(6) 2010.As reported, the patient is making a claim for an adverse patient outcome against the 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) 2010 - patient was diagnosed with ventral incisional hernia thereby underwent laparoscopic repair with the implant of perfix plug (device #1 and device #2).Per operative notes, ¿the peritoneum was dissected from the surrounding soft tissue.A medium sized mesh plug (device #1) was placed and sutured to the transversalis fascia using sutures.Then a defect in the linea alba was closed by small mesh plug (device #2).¿ (b)(6) 2019 - patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent laparoscopic to open repair with removal of perfix plug (device #1) and implant of bard flat mesh (device #3).Per operative notes,"omentum stuck in left lower quadrant hernia was noted.The entire mesh was removed (device #1).A bard flat mesh (device #3) was placed in the subfascial space and secured by sutures.Previously placed mesh (device #2) was appeared to be holding well and preventing a hernia.¿.

• 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: 13934347
• Report Number: 1213643-2022-92648
• Device Sequence Number: 17290735
• Product Code: FTL
• UDI-Device Identifier: 00801741016660
• UDI-Public: (01)00801741016660(17)140828(10)HUTH0957
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K922916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2025

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: 08/28/2014
• Device Catalogue Number: 0112960
• Device Lot Number: HUTH0957
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 03/21/2025; 04/30/2025
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 04/11/2025; 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2009
• 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: 61 YR
• Patient Sex: Female